Navigation Links
Participants in antidepressant drug trials are atypical patients, UT Southwestern researchers report

DALLAS May 13, 2009 One reason antidepressant medication treatments do not work as well in real life as they do in clinical studies could be the limited type of study participants selected, researchers at UT Southwestern Medical Center have found.

"We are basing our judgment of clinical care in the United States on samples of patients that are totally different from the patient population actually treated in primary care and mental health facilities," said Dr. Madhukar Trivedi, professor of psychiatry at UT Southwestern and senior author of a study published in the May issue of the American Journal of Psychiatry. "Antidepressants should not be seen as a panacea. The general belief is that they work well, but they are less effective in real-world practice, and more work is needed."

As part of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study scientists found that only 22 percent of the 2,855 participants treated with a commonly prescribed antidepressant would have met the criteria for inclusion in a typical antidepressant efficacy trial. Those who did meet criteria had shorter bouts of depression, quicker response to medication, less severe side effects and fewer adverse events compared with those people with depression who would have been excluded from such a trial, used to gain Food and Drug Administration approval of the drugs used.

The STAR*D trial was the first large-scale study to define the effectiveness of several treatment steps in primary care and mental health settings for people with depression, Dr. Trivedi said.

The six-year, $35 million STAR*D study is the largest investigation on the treatment of major depressive disorder and is considered a benchmark in the field of depression research. It initially included more than 4,000 people from outpatient treatment sites across the country. About 65 percent of STAR*D participants, however, had a medical co-morbidity such as diabetes that typically would have excluded them from participating in other clinical trials to test the efficacy of antidepressants, said Dr. Trivedi, co-principal investigator of STAR*D.

"Evidence is growing that depression is like other chronic medical illnesses where it's not just one small, short bout, but a longer battle. People with depression may be at higher risk for other illnesses including obesity or diabetes, yet people with these conditions are excluded from drug trials for depression," Dr. Trivedi said.

STAR*D provided evidence for step-by-step guidelines to address treatment-resistant depression. Many treatment-resistant depression patients would be excluded from drug efficacy trials because those trials typically eliminate study candidates who have previously tried treatment, have suicidal thoughts or have other psychiatric illnesses.

"These are the patients impacted by depression the most highest suicide potential, highest unemployment rates, highest social impairment and they are likely to produce poorer outcomes," Dr. Trivedi said. "That population doesn't get studied systematically in traditional pharmaceutical industry studies."

More research involving patients routinely seen in clinical practice coupled with pharmacogenetics is sorely needed to better understand how to best match patients with specific antidepressant treatments, Dr. Trivedi said.

He recommended that clinicians continue to prescribe antidepressants but with more realistic expectations about the disease's long-term nature. Dr. Trivedi said researchers should design future trials in real clinical practice settings where patients have co-morbidities, as he is doing in his current research.


Contact: Lakisha Ladson
UT Southwestern Medical Center

Related medicine news :

1. Help Raise Awareness of Obesity - Annual Walk From Obesity Invites Participants to Join a Walk in Their Local Area
2. AdvaMed 2007 Exceeds Attendance Expectations With More Than 1,100 Participants from 35 States and 25 Countries
3. Knowing doctors financial interests doesnt deter clinical trial participants
4. im Initiative Participants Select UNICEF as Top Charity in First Year of Microsofts Initiative
5. USP announces 2008 summer internship program participants
6. Medical research should include more women participants and examine the role of gender in disease
7. Medical Research Should Include More Women Participants and Examine the Role of Gender in Disease Incidence and Treatment
8. 23rd AIDS Walk Boston Draws Five-Year Record-Setting 20,000+ Participants, Doubles Runners to 600 and Raises $1.2 Million
9. 19th Annual Susan G. Komen National Race for the Cure(R) Draws Nearly 50,000 Participants, Celebrities; Brings Record Funds to National Capital Area
10. Fight Against Breast Cancer Receives Big Boost During Susan G. Komen Detroit Race for the Cure(R) With 344 Participants From Binsons, Northwood
11. 25,000 AIDS Walk San Francisco Participants; 25,000 Reasons Why
Post Your Comments:
(Date:6/27/2016)... ... 2016 , ... "FCPX editors can now reveal their media with growing colorful ... Christina Austin - CEO of Pixel Film Studios. , ProSlice Color brings the ... can now reveal the media of their split screens with growing colorful panels. , ...
(Date:6/26/2016)... ... 2016 , ... Quality metrics are proliferating in cancer care, and are derived ... eye of the beholder, according to experts who offered insights and commentary in the ... Care. For the full issue, click here . , For the American Society ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... First ... United States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell ... facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
(Date:6/23/2016)... 23, 2016 Any dentist who has made an ... current process. Many of them do not even offer this ... and high laboratory costs involved. And those who ARE able ... such a high cost that the majority of today,s patients ... Parsa Zadeh , founder of Dental Evolutions Inc. and ...
(Date:6/23/2016)... a startling report released today, National Safety Council research ... proven plan to eliminate prescription opioid overdoses. Prescription Nation ... tackling the worst drug crisis in recorded U.S. history, assigned a ... , New Mexico , Tennessee ... failing states, three – Michigan , ...
Breaking Medicine Technology: