How Are Depression And The Inability To Express Emotions Related?

Previous research on alexithymia (the inability to express emotions)and depression has led to a controversy over whether alexithymia should be viewed as a state-dependent phenomenon or as a stable personality trait.


The aim of a 5-year follow-up study published in the 2006 March issue of Psychotherapy & Psychosomatics, was to examine the temporal stability of alexithymia in outpatients suffering from major depression. The study population comprised 116 (49 male and 67 female) outpatients with major depression. Alexithymic features were assessed with the Toronto Alexithymia Scale (TAS-20) and the degree of depression with the Beck Depression Inventory. The patients were retested after a period of 5 years. Mean alexithymia and depression scores decreased significantly over the 5-year period.


Alexithymia and depression were associated with each other, but the high test-retest correlations in the TAS-20 scores indicate relative stability of alexithymia. The three factors of alexithymia behaved differently. Difficulty in identifying feelings and difficulty in describing feelings were associated with alleviation of depressive symptoms, whereas externally oriented thinking was not. Alexithymia seems to be related with the severity of depression in outpatients with major depression, but it also shows relative stability over 5 years. These findings support the view that the alexithymia construct represents a stable personality trait, but is also a state-dependent phenomenon.


karger


JOURNAL OF PSYCHOTHERAPY AND PSYCHOSOMATICS


The International Federation for Psychotherapy (IFP) is an organization of national, regional, and school-oriented psychotherapy societies. Its goals are to facilitate and promote international communication among the various schools, professional groups and cultures within psychotherapy. The IFP organizes international congresses and conferences on psychotherapy. The IFP promotes the development of psychotherapy in practice, teaching and research and encourages and supports appropriate standards in the practice of psychotherapy. "Psychotherapy and Psychosomatics" is the official journal of the IFP. IFP, Culmannstrasse 8, CH-8091 Zurich.


JOURNAL OF PSYCHOTHERAPY AND PSYCHOSOMATICS

The Impact Of Antenatal Depression And Early Child Development

A new study published in BJOG: An International Journal of Obstetrics and Gynaecology has found that antenatal depression can have a negative impact on child development.


It is widely accepted that postnatal depression can have a detrimental effect on child development, however few studies have looked at the effect of antenatal depression. This research, which comes from a collaboration between the University of the West of England and the University of Bristol, aimed to assess maternal depression during pregnancy and subsequent child development.


The study, which used data from Children of the 90s (also known as ALSPAC - the Avon Longitudinal Study of Parents and Children)1, included 11 098 women in Avon, England, who had an estimated date of delivery between April 1991 and December 1992.


The research found that children of women with persistent depression during pregnancy have a 50% increase in the odds of developmental delay. The presence of continuing postnatal depression made a contribution, but when the results were adjusted to allow for this, there was still an independent 34% increase in the odds of developmental delay attributable to the antenatal component.


The Edinburgh Postnatal Depression Scale (EPDS)2 was used to assess the level of maternal depression and the Denver Developmental Screening Test II (DDST)3 was employed to assess child development. Women completed the EPDS at 18 and 32 weeks gestation and again at eight weeks and then eight months after birth. Applying the standard 12/13 EPDS cut-off, 1565 (14%) women were depressed antenatally but not at either postnatal time-point. In total 893 (9%) children in the study group were developmentally delayed at 18 months of age.


Researchers found that persistent antenatal depression (EPDS ?‰? 10 at both 18 and 32 weeks) was associated with developmental delay with an adjusted odds ratio of 1.34 (adjusted OR 1.34, 95% CI 1.11-1.62). Applying the 12/13 and 14/15 cut-offs gave similar results. After adjustment for postnatal depression, the effect sizes were reduced but still very significant.


Dr Toity Deave, Research Fellow, Centre for Child & Adolescent Health, University of the West of England, said: "I believe the most important finding from our study is that maternal antenatal depression has a negative impact on children's cognitive development, even when postnatal depression has been taken into account. The other important message is that it is the persistence of depression, as well as the intensity of antenatal depression, that has an impact on the child."


Professor Philip Steer, BJOG Editor-in-Chief said: "Although there is clear evidence that women who experience antenatal depression are more likely to develop postnatal depression, little research has looked separately at antenatal depression and its effects on child development. This study is important because it has done just that and has found a significant link.















"Maternal depression, both antenatally and postnatally, has a significant impact on women and their families. It is essential for doctors, midwives and other healthcare professionals to be aware and play an active role in assessing and identifying maternal depression, so that those at-risk can receive appropriate support and care during pregnancy and post-birth."


Notes


BJOG: An International Journal of Obstetrics and Gynaecology is owned by the Royal College of Obstetricians and Gynaecologists (RCOG) but is editorially independent and published monthly by Wiley-Blackwell. The journal features original, peer-reviewed, high-quality medical research in all areas of obstetrics and gynaecology worldwide. Please quote 'BJOG' or 'BJOG: An International Journal of Obstetrics and Gynaecology' when referring to the journal.


Children of the 90s (also known as ALSPAC - the Avon Longitudinal Study of Parents and Children) is a unique ongoing research project based in the University of Bristol. It enrolled 14,000 mothers during pregnancy in 1991-2 and has followed most of the children and parents in minute detail ever since.
The Children of the 90s study could not have been undertaken without the continuing financial support of the Medical Research Council, the Wellcome Trust, and the University of Bristol among many others.


The Edinburgh Postnatal Depression Scale is a widely used 10-item self-rating questionnaire on which women rate their feelings over the previous seven days, giving a score ranging from 0 to 30. The scoring system is effective for both antenatal and postnatal depression, the standard cut-off point for women who are at risk or suffering from ante or postnatal depression is a score of 12-13/30.


The Denver Developmental Screening Test II (DDST) is a screening questionnaire designed to identify cognitive and behavioural problems in preschool children. The children were screened at 18 months of age and the developmentally delayed group were those who failed two or more items.


Reference


Deave T, Heron J, Evans J, Emond A. The impact of maternal depression in pregnancy on early child development. BJOG 2008;115:1043-1051.

Royal College of Obstetricians and Gynaecologists

Samaritans Rap Encourages Teenagers To Speak Out About Mental Health, UK

Samaritans is releasing a rap song entitled '1 in 10 (talk to someone)' to challenge the stigma surrounding mental health and encourage young people to speak about problems before they escalate.



'1 in 10 (talk to someone)' is inspired by the story of Shirley Smith, a mother who lost her 19-year-old son Daniel to suicide in March 2005. Shirley said: "The sadness and ache in our hearts is unbearable at times but we made a conscious decision after Dan's death to tell our story, to try to encourage young people to talk about their problems, not to keep them bottled up so they destroy you."



The song was written and performed by students from Thornhill Business and Enterprise School in Sunderland and produced by Occupational Therapist Graeme Smith, who worked with students who wanted to do something positive and productive after a 13-year-old pupil at the school took his own life last year.



Graeme said: "We have a further seven songs written, performed or inspired by people who have direct experience of mental health services. Behind each song is a powerful story which we believe challenges mental health stigma and creates a message of hope, recovery and resilience."



"The students at Thornhill Business and Enterprise School have been directly affected by suicide and I believe this project has really influenced the lives of the young people in a positive way and changed their perception of mental health completely".



Shirley said: "The lyrics really moved me when I first heard them and when I saw the video it was incredible. The message is simple; 'talk to someone' if you feel low, please do not think you are alone. There is always someone, your parents, a friend, a teacher, a doctor or Samaritans. Please don't suffer in silence."



Suicide is the biggest killer of young men under the age of 35 and around one in ten young people will experience a mental health problem each year. Funds raised from the song will go to support the work of Samaritans and Comic Relief's campaign to combat mental health stigma. The DVD of '1 in 10 (talk to someone)' is supported by the Radio One Chris Moyles Breakfast Show and features an introductory message of support for young people from radio personality Chappers. Funding for the project was supplied by the Care Services Improvement Partnership (CSIP) and Samaritans. The compilation CD featuring rock, pop, and R& B tracks will be released later this year.



'1 in 10 (talk to someone)' is available for download on ITunes from Monday 16th June and DVDs and ring tones can be ordered online at yourlifeline.uk.The DVD was shot in Sunderland and has been nominated for the Health and Social Care Awards 2008.


Clilck here for an image of the CD.






It is the aim of Samaritans to make emotional health a mainstream issue. Samaritans' vision is for a society where fewer people die by suicide because people are able to share feelings of emotional distress openly without fear of being judged. Samaritans believes that offering people the opportunity to be listened to in confidence, and accepted without prejudice, can alleviate despair and suicidal feelings.



Samaritans is a registered charity, founded in 1953, which offers 24-hour confidential emotional support to anyone in emotional distress. The service is offered by 16,800 trained volunteers and is entirely dependent on voluntary support. Across the UK, you can call Samaritans on 08457 90 90 90 (1850 60 90 90 in the Republic of Ireland) email, write to Samaritans at Chris, PO Box 9090, Stirling, FK8 2SA, or if you are deaf or hard of hearing use the single national minicom number 08457 90 91 92. Log on to samaritans for more information. Calls from BT will be charged at up to 4 pence per minute at all times. A call set-up fee of 3 pence per minute applies to calls from residential lines. Mobile and other providers' charges may vary.



samaritans

Efficacy Similar Among Antidepressants, Side Effects Drive Multiple Prescriptions

A review of 293 studies that assessed 12 commonly prescribed second-generation antidepressants found no significant differences between the drugs for the treatment of acute-phase depression, according to a report by the RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center.


However, side effects among the drugs varied, causing many patients to have to try more than one before settling on long-term therapy.


The drugs reviewed were bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, trazodone and venlafaxine. The studies included randomized controlled trials with active or placebo controls, observational studies and systematic reviews.


"Based on our review of the available research, we found very little difference in the effectiveness of various antidepressants," said Dr. Gerald Gartlehner, lead author of the report and a research associate at UNC's Sheps Center for Health Services Research.


Despite their similarities, the drugs create different side effects that lead only about 60 percent of patients to respond to an initial treatment regimen, said Linda Lux, an RTI researcher. And, she said, 61 percent of patients in efficacy trials experienced at least one adverse side effect, including constipation, diarrhea, dizziness, headache, insomnia and vomiting.


"Because of the high incidence of side effects, many patients try more than one medication before finding an effective treatment," Lux said. "Predicting which one will be most effective or best tolerated by any individual is not yet possible."


"This study highlights the important issue that side effects happen to patients, not doctors, and we need to take them a bit more seriously," said Dr Howard McLeod, director of the UNC's Institute for Pharmacogenomics and Individualized Therapy.


McLeod, who was not part of this study, and others at UNC are trying to solve this drug-prescribing dilemma by using a patient's DNA to help direct the selection of treatment.


Gartlehner and Lux said more research is also needed to determine the effects that dosage and duration of second-generation antidepressant treatment have on efficacy, and to see if efficacy differs in patients who also suffer from anxiety, insomnia, pain or fatigue.


The project was supported by the Agency for Healthcare Quality Research, and is posted on the agency's Web site: ahrq.


University of North Carolina at Chapel Hill

210 Pittsboro St. Campus Box 6210

Chapel Hill, NC 27514

United States

unc/

Royal College Of Psychiatrists Responds To The Healthcare Commission's Review Of NHS Acute Inpatient Mental Health Services

The Royal College of Psychiatrists welcomes this detailed review of NHS acute inpatient mental health services by the Healthcare Commission.



It is encouraging to see that two-fifths of trusts exceeded the minimum level of service provision. However, it is disappointing that no trusts were scored excellent on all four of the key criteria against which performance was assessed.



Professor Dinesh Bhugra, president of the Royal College of Psychiatrists, said: "It is a matter of great concern to us that, according to the Healthcare Commission's analysis, trusts scoring 'weak' not only operate larger wards but are more likely to be serving an urban, more deprived population. There is a postcode lottery in terms of mental health services, and these types of inequalities should be unacceptable in this day and age."



The Royal College of Psychiatrists acknowledges that some progress has been made in bringing average bed occupancy rate down, and congratulates trusts who have made improvements. But significant variations remain.



Prof Bhugra said: "We are pleased that the average bed occupancy rate is now down to 87%. However, this figure conceals major regional variation. As the report points out, there has been an 'escalation' of bed occupancy rates in some areas. Two-fifths of trusts have occupancy rates over 90% and one in 10 have rates in excess of 100%.



"We note with interest that these trusts serve more urban-based populations and have a higher number of service users from black and minority ethnic groups. We are concerned that there are particular groups of people who are still not getting the quality of care they deserve. We agree that more work needs to be done in partnership with patients and carers. Our Fair Deal campaign deals with many of these issues and we look forward to developing these themes further."



Prof Bhugra paid tribute to the dedication of mental health professionals across England. He said: "We appreciate the hard work that staff are putting in under difficult circumstances. However, as this report highlights that there remain clear gaps in staff training which must be taken on board by service providers. For example, only a quarter of staff say they have received training in how to ask service users about their use of alcohol or drugs. We need improved training for staff on working with people with a dual diagnosis."



The Royal College of Psychiatrists is delighted that the Healthcare Commission has acknowledged the success of a number of College initiatives on quality assurance, such as the Accreditation for Acute Mental Health Services (AIMS) and the ECT Accreditation Service (ECTAS).



Many of the recommendations made in the report tie in closely with the College's current work. Professor Sue Bailey, the Registrar of the Royal College of Psychiatrists, said: "We are very pleased that one of the Healthcare Commission's key priorities is to increase the effectiveness of the acute care pathway (priority area 4). This is a priority for us too, and we are currently recruiting a new College lead on pathways of care."



Prof Bailey continued: "Other priorities identified by the Commission include ensuring the safety of service users, staff and visitors (priority area 2), and providing appropriate and safe interventions (priority area 3). Within the last two months, the Royal College of Psychiatrists has published two reports on these issues. Our Rethinking Risk document makes ten recommendations to improve the assessment and management of risk, which the College is already working on with other agencies. And our Psychological Therapies report outlines ways to improve the provision of these therapies in both primary and secondary care settings."



Prof Bhugra concluded: "The Royal College of Psychiatrists looks forward to continuing its work with the Healthcare Commission and other key stakeholders on improving the quality of mental health services across all jurisdictions."


The Royal College of Psychiatrists' Fair Deal for Mental Health manifesto was launched on 2 July 2008. Visit fairdeal4mentalhealth.co.uk



The Royal College of Psychiatrists' recent reports, Psychological Therapies in Psychiatry and Primary Care and Rethinking Risk to Others in Mental Health Services are available here.

Battling Depression in Children

Depression is the leading cause of disability in the United States. It now occurs earlier in life [11] and affects up to 3 percent of children ages 6 to 12 and 7 percent of teenagers. Current research suggests that young people's symptoms are similar to those in adults: persistent sadness, irritability, crying, poor sleep, doing poorly at school and distance from one-time friends. [12]


Hope and Caution


Parents may find a depressed child daunting, but treatment can be very effective. Psychotherapy can help, and one antidepressant drug (fluoxetine, or Prozac) has proved successful in clinical trials and is approved for use with children. "Depression has serious consequences and results," says child psychiatrist David Fassler, M.D. "The most dangerous thing we can do is not treat these kids."


Potential Dangers


Reports of suicidal behavior in children who are taking SSRI antidepressants have moved the Food and Drug Administration to commission a study. Suicidal or self-destructive behavior early in drug treatment may be due to the drugs or the severity of the disease, or it may represent an interim effect as depressed people gain renewed energy and take action on suicidal thoughts as medication begins to work. The FDA recommends close monitoring of patients who start or change antidepressant medications. [13]


The Facts:


-- A recent evidence-based review of several psychotherapeutic approaches concluded that cognitive-behavioral therapy, which seeks to adjust the patient's thoughts, feelings and behaviors, is "currently the treatment of choice for anxiety and depressive disorders in children and adolescents." [1]


-- In a study of 123 depressed adolescents with at least one depressed parent, 9.3 percent of those treated with cognitive behavioral therapy remained depressed, compared to 28.8 percent in the control group. [7]


-- A meta-analysis covering 61,424 children found that girls' depression scores stay steady from ages 8 to 11 and then increase between ages 12 and 16. Boys' scores were stable from 8 to 16, with a high score at age 12. Hispanic youth had significantly higher depression scores than black and white children, and there were no socioeconomic effects observed. [2]


-- Once puberty begins, girls are twice as likely as boys to become depressed. This may be due to a combination of genetic background, normal hormonal changes and social factors. Close attention to pubescent girls could prevent depression or facilitate intervention when it is observed. [3]















-- Children and adolescents with depression or bipolar disorder are largely untreated, perhaps because psychiatrists and pediatricians receive little or no training in children's mental health. As a result, treatments may reflect adult treatment plans that have not been proven to work with youths. Effective treatments have been identified, but they are not yet widely used. [4]


-- Suicidal behavior among 10- to 19-year-olds and other age groups is no more likely with newer, SSRI antidepressants than with older drugs, according to a recent study of 159,810 patients in Britain. [5]


-- Suicidal behavior is associated with antidepressant therapy because the sickest patients are the ones most likely to be prescribed antidepressants. [6]


-- Parental support for adolescent girls decreases the risk of depression, while existing depression is tied to decreases in peer support. [8]


-- Some drugmakers have been accused of hiding clinical trial data indicating that two SSRIs, Paxil and Zoloft, may carry more risks than benefits. [10]


-- Researchers at the National Institute of Mental Health are using functional magnetic resonance imaging to scan brains of people with depression and compare them to mentally healthy volunteers. They're looking at the networks of interactions between brain structures, at how these specific regions are affected by depression and treatment, and at alternative genetic structures and brain functioning. [9]


Choices for Treatment…..CONTINUES….Centers for the Advancement of Health


Huge database of hospitals world wide


View drug information on Paxil CR; Prozac Weekly; Zoloft.

StuCNS Response REEG-Guidance For Resistant Depression Superior To APA Guidelines Most Commonly Used By Payers, Study

CNS Response, Inc.
(OTCBB: CNSO) reported the results of a study by the Center for
Health Economics, Epidemiology, and Science Policy at United
BioSource Corporation, a global pharmacoeconomic research firm and
one of the most experienced firms providing evidence-based review of
innovative healthcare technologies.



The study, entitled "Comparing Levels of Evidence for Treatment of
Treatment-Resistant Depression with Referenced-EEG(R) to Current
Practice," analyzed published studies on treatment-resistant
depression (TRD), and modeled the evidence for Referenced-EEG (rEEG)
against evidence for currently reimbursed therapies. The study is
available on the CNS Response website, cnsresponse.



Evidence supporting rEEG appears superior to that supporting APA
(American Psychiatric Association) or TMAP (Texas Medication Algorithm
Project) treatment guidelines, wrote investigator Mkaya Mwamburi, MD,
PhD. "The findings of this project provide a compelling basis for the
consideration of rEEG as a beneficial modality of medication selection
for the treatment of TRD. These findings may warrant the
consideration of rEEG for inclusion in treatment guidelines and
perhaps a basis for re-imbursement," concluded Dr. Mwamburi.



Depression affects 18.8 million people in the U.S. The financial
implications of the disease are extraordinary, estimated at $83
billion annually, including the cost of more than 11.4 million
prescriptions for depression being written by physicians monthly.



"This study has broad implications for payers who believe there is
adequate evidence supporting therapies they reimburse," commented
George Carpenter, President of CNS Response. "But numerous studies,
such as STAR*D (Sequenced Treatment Alternatives to Relieve
Depression), have demonstrated high failure rates and very little
evidence for the treatment of TRD patients. The published evidence on
rEEG, as assessed by United BioSource, compares favorably in academic
rigor and clinical outcomes. Payers utilizing rEEG can now pay for
treatments with better patient outcomes, lower costs, and superior
evidence," added Carpenter.



Consulting Actuary Steve Melek of Milliman Global noted, "The impact
on payers couldn't come at a better time. The $30 billion U.S. payers
spend on retail prescription drugs for mental disorders is frequently
ineffective in achieving disease remission. With the passage of
mental health parity legislation, there is a great opportunity for
improvement in effective diagnosis and treatment of depression, both
in primary and specialty care settings. Payers could greatly benefit
from such improvements, leading to better clinical and financial
outcomes."
















"In summary," said CNS Response CEO Len Brandt, "United BioSource
Corporation is one of the most experienced and trusted firms for
evidence-based review of innovative healthcare technologies. With the
recent passing of legislation mandating that behavioral care now be
treated on parity with other medical care, we believe the United
BioSource analysis of rEEG and the Analysis Group's recent rEEG
economic impact study arms corporations, their insurance companies,
and managed care vendors with the knowledge that rEEG is
evidence-supported and economically beneficial to all concerned. We
are positioned to provide significant benefit to patients, payers and
providers."



About CNS Response



CNS Response is a life-sciences data company whose patented system
provides treatment guidance to psychiatrists and other physicians for
patients with behavioral (mental or addictive) disorders. This
technology allows CNS Response to create and provide simple reports
("rEEG(R) Reports") that specifically guide physicians to treatment
strategies based on the patient's own physiology.



rEEG utilizes traditional electroencephalography (EEG) in conjunction
with a normative database and a proprietary clinical (symptomatic)
database to identify the following: (1) medication classes most
likely to be needed; and (2) medications within these classes with
the most probable treatment potential for each patient. Reports are
provided to physicians in a relationship analogous to that of a
reference laboratory. Prospective, retrospective and field studies of
treatment-resistant patients have reported treatment success of 70%
or greater in managed care, outpatient psychiatric and residential
substance abuse clinical settings.



In addition to providing analytical support to physicians, CNS
Response is also an aid to pharmaceutical developers, who can use
rEEG to (1) stratify study populations to improve the success of FDA
clinical trials; (2) provide insight on effective therapeutic dosing
of investigational drugs; (3) identify additional indications for
psychiatric medications; (4) provide insight into effective drug
combinations; and (5) discover opportunities for decision analytics
and support. In addition to these applications, CNS Response
continues to investigate the use of rEEG analysis for development of
proprietary pharmaceutical opportunities.



About United BioSource Corporation (UBC)



UBC is a global pharmaceutical services organization that helps
emerging and established life science companies develop and
commercialize medical products. UBC specializes in offering new and
innovative ways to study drugs and devices by providing expertise in
science, strategy and execution. UBC is headquartered in Bethesda,
Maryland, with offices in the United States, Canada, Eastern and
Western Europe and South America. For more information, visit
unitedbiosource or call +866-458-1096.



Safe Harbor Statement Under the Private Securities Litigation Reform
Act of 1995



Except for the historical information contained herein, the matters
discussed are forward-looking statements made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of
1995, as amended. These statements involve risks and uncertainties as
set forth in the Company's filings with the Securities and Exchange
Commission. These risks and uncertainties could cause actual results
to differ materially from any forward-looking statements made herein.

United BioSource Corporation

Antidepressants May Cut Off Blood Flow To Brain, But Don't Stop Your Meds

In a new study presented this week in New Orleans at the American College of Cardiology's annual conference has found that antidepressants are related to about a 5% increase in clogging of the carotid artery, which carries blood to the brain directly. There carotid arteries are located on each side of your neck under the jaw line.


Carotid artery disease is a condition in which these arteries become narrowed or blocked. When the arteries become narrowed, the condition is called carotid stenosis. However, there is little to no concern for those taking depression medications and should not discontinue their treatments.


Dr. Gregg C. Fonarow, a professor of cardiology at the University of California, Los Angeles says:


"Antidepressant medications may decrease cardiovascular risk by treating depression. Patients should not be concerned or stop taking antidepressant medications on the basis of this study."


It is important to note that according to experts, studies presented at medical conferences do not undergo the same vetting as research published in peer-reviewed journals, although the study was funded by the U.S. National Institutes of Health.


To try to isolate the effect of antidepressants on blood vessels, the researchers measured the thickness of the carotid artery, called carotid intima-media thickness. The study authors found that a twin taking an antidepressant had a greater intima-media thickness than a brother not taking the drugs.


Dr. Amit Shah, a cardiology fellow at Emory University explains:


"There is a clear association between increased intima-media thickness and taking an antidepressant, and this trend is even stronger when we look at people who are on these medications and are more depressed. Because we didn't see an association between depression itself and a thickening of the carotid artery, it strengthens the argument that it is more likely the antidepressants than the actual depression that could be behind the association."


The findings also held true after compensating for such factors as age, diabetes, blood pressure, current or previous smoking, cholesterol and weight. Other factors weighed included depressive symptoms, history of major depression and heart disease, alcohol and coffee use, statin use, physical activity, education and employment, the researchers said.


It's not clear why there might be an association between antidepressant use and heart disease. These drugs increase levels of the brain chemicals serotonin and norepinephrine, which are often low in depressed individuals. Shah said increased levels of these chemicals may cause blood vessels to tighten, and this may lead to reduced blood flow to organs and higher blood pressure, which is a risk factor for atherosclerosis.


Dr. Dominique L. Musselman, an associate professor of clinical psychiatry at the University of Miami Miller School of Medicine comments:


"This finding is somewhat counterintuitive since it is well known that SSRIs enhance a tendency to bleed. This is an important finding that needs to be replicated."


Again, Musselman also strongly advises patients not to stop taking antidepressants based on this study. Not treating depression can have serious consequences for quality of life, survival after a heart attack or other cardiovascular events, she said.

Primary Care Should Have Systems In Place For Screening And Treating Depression, ACPM Recommends

The American College of Preventive Medicine (ACPM) supports the recommendations of the US Preventive Services Task Force (USPSTF) that primary care providers should screen all adults for depression, and further recommends that all primary care providers should have systems in place to ensure the accurate diagnosis and treatment of this condition. The earliest and best opportunities to identify depression are in the clinics of primary care providers and all primary care practices should have such systems of care in place.



According to Dr. Michael T. Compton, one of the lead authors of ACPM's recommendation, "Depressive disorders are common in primary care settings and are associated with substantial morbidity and disability for individuals, as well as direct and indirect costs to society. Yet, depression is a highly treatable condition, and the goal of treatment is complete recovery. We believe that all primary care providers should be equipped to screen for depression and to assure timely and adequate treatment, either in their own practices or through an established system of referral to mental health professionals."



Depression is a potentially life-threatening disorder that affects approximately 14.8 million Americans 18 years of age and older in a given year. Depression also affects many people younger than age 18. The STAR*D (Sequenced Treatment Alternatives to Relieve Depression) study found that nearly 40% had their first depressive episode before the age of 18.



According to Dr. Mark B. Johnson, President of ACPM, "Depression is a major concern in the United States that leads to devastating consequences in many families. ACPM will continue to monitor emerging evidence on ways to prevent, screen for and treat this disease."



ACPM's practice position statement on screening adults for depression appears in the October 2009 issue of the Journal of Family Practice. The statement can be viewed at acpm/pol_positionstate.htm.

ABILIFY (aripiprazole) Effictive As Maintenance Therapy In Adults With Bipolar I Disorder Following Treatment For A Recent Manic Or Mixed Episode

Maintenance therapy with the Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. atypical antipsychotic ABILIFY (aripiprazole) significantly delayed the time to relapse in adults with Bipolar I Disorder who had been stabilized and maintained on ABILIFY for at least six (6) weeks, according to findings of a randomized, double-blind placebo-controlled study of patients with a recent manic or mixed episode published in the current issue of the Journal of Clinical Psychiatry.1 These study results were based on rigorous criteria used to define stability for Bipolar I Disorder.


"These findings are important because Bipolar I Disorder is a lifelong episodic illness and an important goal of treatment is to prevent or delay recurrent mood symptoms," said lead investigator Paul E. Keck, Jr., M.D., professor of psychiatry and pharmacology and vice chairman for research, Department Of Psychiatry, University Of Cincinnati College Of Medicine. "Up to 40 percent of adults who respond to initial treatment have relapses within one year,2,3 emphasizing the need for maintenance treatment."


Bipolar I Disorder can be treated with antipsychotic medications.4 ABILIFY is one of only two atypical antipsychotics indicated for maintenance therapy in Bipolar I Disorder. ABILIFY (aripiprazole) is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder, and for maintaining efficacy in adults with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least six (6) weeks. Physicians who elect to use ABILIFY for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual.


Study Design and Findings


In the study, adults with Bipolar I Disorder who had recently been hospitalized and treated for a manic or mixed episode were initially stabilized with ABILIFY monotherapy (15 or 30 mg/day for 6-18 weeks). In the open-label stabilization phase, the adults in the study were required to maintain a total score of 10 or less on the Young Mania Rating Scale (YMRS) and 13 or less on the Montgomery-Asberg Depression Rating Scale (MADRS) for six (6) consecutive weeks prior to randomization into the double-blind phase. In the double-blind phase, 161 adults were randomly assigned to ABILIFY or placebo and monitored for relapse. The primary endpoint was time to relapse for a manic, mixed, or depressive episode. Relapse was defined by a discontinuation from the study attributed to a lack of efficacy (indicated by hospital admission for a mood episode, or addition to or increase in psychotropic medication other than ABILIFY to treat affective symptoms).


Results from the study show:


-- ABILIFY was superior to placebo in delaying the time to relapse (p=0.020; hazard ratio=0.52).















-- Adults treated with ABILIFY experienced significantly fewer relapses than placebo: 25 percent vs 43 percent (p-value equals 0.013), respectively.


-- Adults treated with ABILIFY experienced fewer manic relapses than placebo: 8 percent vs 23 percent (p-value equals 0.009), respectively.


The majority of relapses were due to manic rather than depressive symptoms. There were insufficient data to know whether ABILIFY is effective in delaying the time to occurrence of depression in adults with Bipolar I Disorder.


More adults in the placebo group than in the ABILIFY (aripiprazole) group (19.3 percent vs 10.4 percent, respectively) discontinued the study because of treatment-emergent adverse events. Adverse events among adults treated with ABILIFY with an incidence of 5 percent or more and at least twice the rate of placebo were: tremor (9.1%), akathisia (6.5%), vaginitis (6.4%), and pain in the extremities (5.2%). The safety profile demonstrated during this trial was generally consistent with data reported in other long-term placebo controlled trials of ABILIFY including changes in weight, prolactin, QTc and Extrapyramidal symptoms.5


About Bipolar Disorder6


Bipolar disorder, formerly called manic-depressive illness, is a condition that affects more than two million Americans. People who have this illness tend to experience extreme mood swings, along with other specific symptoms and behaviors. These mood swings or "episodes" can take three forms: manic episodes, depressive episodes, or "mixed" episodes. The symptoms of bipolar disorder are thought to be caused by an imbalance of key chemicals in the brain. Although there is no cure for bipolar disorder, medicine can play a key role in helping to manage symptoms and extreme mood swings.


About ABILIFY


In addition to its specific indications for Bipolar I Disorder, ABILIFY is indicated for the treatment of schizophrenia including maintaining stability in adults who had been symptomatically stable on other antipsychotic medications for periods of three months or longer and observed for relapse during a period of up to 26 weeks. Physicians who elect to use ABILIFY for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual. Since its initial approval in 2002, more than seven million prescriptions have been written in the United States.7


ABILIFY is available by prescription only. ABILIFY tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. The effective dose range is 10-30 mg/day for schizophrenia patients, and 15 or 30 mg/day for Bipolar I Disorder patients. In addition to administration as a tablet, ABILIFY is available in a 1 mg/mL nonrefrigerated oral solution. The safety of doses of ABILIFY above 30 mg/day has not been evaluated in clinical trials.


ABILIFY is taken once daily with or without food.


It is important to talk to a healthcare provider for more information about ABILIFY (aripiprazole). To learn more about ABILIFY and for FULL PRESCRIBING INFORMATION, including Boxed WARNING, please visit abilify.


IMPORTANT SAFETY INFORMATION for ABILIFY:


Increased Mortality in Elderly Patients With Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular or infectious in nature. ABILIFY is not approved for the treatment of patients with dementia-related psychosis (see Boxed WARNING).


ABILIFY is contraindicated in patients with a known hypersensitivity to the product.


As with all antipsychotic medications, including ABILIFY, a rare condition referred to as neuroleptic malignant syndrome (NMS) has been reported. As with all antipsychotic medications, prescribing should be consistent with the need to minimize the risk of tardive dyskinesia (TD).


Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported at an increased incidence in clinical trials of elderly patients with dementia-related psychosis treated with ABILIFY, including a significant dose response relationship in a fixed-dose trial. ABILIFY is not approved for the treatment of patients with dementia-related psychosis.


Hyperglycemia, including some serious cases ranging from ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. Patients on ABILIFY should be appropriately tested before and monitored during treatment.


ABILIFY may be associated with orthostatic hypotension and should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would predispose them to hypotension.


As with other antipsychotic drugs, ABILIFY (aripiprazole) should be used with caution in patients with a history of seizures or with conditions that lower the seizure threshold.


Like other antipsychotics, ABILIFY may have the potential to impair judgment, thinking, or motor skills. Patients should not drive or operate hazardous machinery until they are certain ABILIFY does not affect them adversely.


Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.


As antipsychotics have been associated with esophageal dysmotility and aspiration, ABILIFY (aripiprazole) should be used cautiously in patients at risk for aspiration pneumonia.


As the possibility of a suicide attempt is inherent in psychotic illness and bipolar disorder, close supervision of high-risk patients should accompany drug therapy.


Prescriptions for ABILIFY should be written for the smallest quantity consistent with good patient management to reduce the risk of overdose.


Physicians should determine if a patient is pregnant or intends to become pregnant while taking ABILIFY. Patients should be advised not to breast-feed while taking ABILIFY.


Patients should be advised to avoid alcohol while taking ABILIFY.


Both CYP3A4 and CYP2D6 are responsible for ABILIFY metabolism. Agents that induce CYP3A4 (e.g., carbamazepine) could cause an increase in ABILIFY clearance and lower blood levels. Inhibitors of CYP3A4 (e.g., ketoconazole) or CYP2D6 (e.g., quinidine, fluoxetine, or paroxetine) can inhibit ABILIFY elimination and cause increased blood levels.


Commonly observed adverse events reported with ABILIFY in 3-week bipolar mania trials at a greater than or equal to 5% incidence for ABILIFY and at a rate at least twice the rate of placebo include, respectively, akathisia (15% vs. 4%), constipation (13% vs. 6%), and accidental injury (6% vs. 3%).


Treatment-emergent adverse events reported with ABILIFY in short-term trials at an incidence greater than or equal to 10% and greater than placebo, respectively, include headache (31% vs. 26%), agitation (25% vs. 24%), anxiety (20% vs. 17%), insomnia (20% vs. 15%), nausea (16% vs. 12%), dyspepsia (15% vs. 13%), somnolence (12% vs. 8%), akathisia (12% vs. 5%), lightheadedness (11% vs. 8%), vomiting (11% vs. 6%), and constipation (11% vs. 7%).


The adverse events reported in a 26-week, double-blind schizophrenia trial comparing ABILIFY (aripiprazole) and placebo were generally consistent with those reported in the short-term, placebo-controlled schizophrenia trials, except for a higher incidence of tremor: 9% for ABILIFY vs. 1% for placebo.


About Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.


Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in the development and commercialization of ABILIFY (aripiprazole) in the United States and major European countries.


ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: "Otsuka - people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for the treatment of disease and consumer products for the maintenance of everyday health. The Otsuka Pharmaceutical Group comprises 81 companies and employs approximately 26,000 people in 16 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned US $6.2 billion in consolidated annual revenues in fiscal 2004.


Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.


For more information and FULL PRESCRIBING INFORMATION including Boxed WARNING,
visit: abilify


Visit Otsuka Pharmaceutical Co., Ltd. at: otsuka-global


References:


1 - Keck PE Jr., Calabrese Jr., McQuade RD, Carson W, Carlson BX, Rollin LM, Marcus RN, Sanchez R, and the Aripiprazole Study Group. A placebo-controlled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder. J Clin Psych 2006;67:626-37.


2 - Gitlin MJ, Swendsen J, Heller TL, Hammen C: Relapse and impairment in bipolar disorder. Am J Psychiatry 1995; 152:1635-1640.


3 - O'Connell RA, Mayo JA, Flatlow L, Cuthbertson B, O'Brien BE: Outcome of bipolar disorder on long-term treatment with lithium. Br J Psychiatry 1991;159:123-129.


4 - American Psychiatric Association. Practice guideline for the treatment of patients with bipolar disorder (second edition). Executive summary of recommendations. Copyright 2002 American Psychiatric Association. Also available at: psych/psych_pract/treatg/pg/bipolar_revisebook_1.cfm#parta-1.


5 - Pigott TA, Carson WH, Saha AR, Torbeyns AF, Stock EG, Ingenito GG; Aripiprazole Study Group. Aripiprazole for the prevention of relapse in stabilized patients with chronic schizophrenia: a placebo-controlled 26-week study. J Clin Psychiatry. 2003 Sep;64(9):1048-56.


6 - What is Bipolar Disorder? Available at: abilify/abilify/channels/bipolar_content.jsp?BV_UseBVCookie=Yes&channelName=Bipolar%2fBP_Disorder&programName=&referrer=null


7 - IMS Auditrac NGPS: Abilify Total Monthly Retail Prescriptions: Data Accessed 04/24/2006.


View drug information on Abilify.