[Editor’s note: It is my pleasure to share with SPNAC readers the first guest article to be posted on Suicide Prevention News and Comment. Several other noteworthy authors have been invited to make contributions, and I am hopeful that items such as this will become a regular feature. FJC]
By DeQuincy A. Lezine, Ph.D.
Patients in antidepressant drug trials are not representative of patients in the United States who might need antidepressant medication. That is the conclusion of a recent study by Dr. Madhukar Trivedi of the University of Texas Southwestern Medical Center and colleagues appearing in the May issue of the American Journal of Psychiatry. The report comes from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, funded by the National Institute of Mental Health (NIMH). The $35 million study included 2,855 patients with depression and lasted six years.
MedPage Today senior editor John Gever writes in a May 14 article that pharmaceutical drug trials for antidepressants generally exclude many potential participants, such as those with “more than one concurrent general medical condition or Axis I psychiatric disorder in addition to depression, or current episodes lasting more than two years.” A May 12 article in The Medical News notes that potential participants “who have previously tried treatment, have suicidal thoughts or have other psychiatric illnesses” would have been excluded. In fact, nearly 80 percent (4 out of 5) of the patients included in STAR*D would have been excluded from other antidepressant clinical trials.
The problem of excluding suicidal individuals from research studies has been noted for some time, with some solutions initially covered in a 2001 article by Jane Pearson (NIMH) and colleagues. This research issue will only intensify as we continually recognize and treat depression and other mental illnesses earlier, especially if we continue to find that comorbidity is the norm rather than the exception.
While prior studies have noted that patients in drug trials differed from other patients based on demographics and clinical characteristics, the current study also documented differences in outcomes. According to the MedPage Today article, findings from drug trials probably “paint a rosier picture than should be expected in ordinary practice” because patients who would have been excluded from drug trials
- were less likely to respond well to the antidepressants (39%) compared to those included in drug trials (52%) …
- were less likely to achieve remission from depression (25%) compared to those included in drug trials (34%) …
- were more likely to require psychiatric hospitalization (2.5%) compared to those included in drug trials (0.3%) …
- were more likely to experience severe or intolerably intense side effects compared to those included in drug trials.
These findings call into question whether the information provided to patients who receive antidepressant medications overstates the potential benefits, including response rates, and understates the potential side effects and risks. Can patients truly give informed consent without accurate information?
According to Dr. Trivedi, “We are basing our judgment of clinical care in the United States on samples of patients that are totally different than the patient population actually treated in primary care and mental health facilities.” The patients who would have been included in drug trials 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” [continued … read the full article here].
[The abridged URL for this post is http://tinyurl.com/SafelyInclude .]