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

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.

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Aripiprazole Boosts Efficacy of Antidepressants in Older Patients With Major Depressive Disorder: Presented at AAGP

Adjunctive aripiprazole appears to be effective in relieving the symptoms of depression in patients aged 50 years or older, according to research presented at the American Association for Geriatric Psychiatry (AAGP) 22nd Annual Meeting.

J. Craig Nelson, MD, University of California San Francisco School of Medicine, San Francisco, California, and colleagues presented the findings here on March 6. According to the researchers, the treatment effect of selective serotonin-reuptake inhibitors is generally minimal in elderly patients with major depressive disorder. The current study sought to determine whether adjunctive aripiprazole might benefit this population when added to standard antidepressant treatment.

Aripiprazole is an atypical antipsychotic currently approved for use only as an adjunct to antidepressant medication.

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Agomelatine Approved in EU for Major Depressive Episodes

The European Commission has granted marketing authorisation for agomelatine (Valdoxan) for the treatment of adult patients with major depressive episodes.

The approval is based on both short-term and long-term results from a large, comprehensive, international development programme including almost 6,000 adult patients with depression.

The results demonstrated the superior efficacy of agomelatine as compared with placebo, selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitor (SNRI) treatments.

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Is There Really an Epidemic of Depression? A new book argues that the mental illness is being overdiagnosed

LEHRER: In your book, you take a critical look at major depressive disorder (MDD), a mental illness that will afflict approximately 10 percent of individuals at some point during their life. In recent decades, the number of cases of MDD has sharply increased. Are we currently experiencing an epidemic of depression? Or is this surge due to changes in diagnosis?

HORWITZ AND WAKEFIELD: Our book argues that, despite widespread beliefs to the contrary, the rate of depressive disorders in the population has not undergone a general upsurge. In fact, careful studies that use the same criterion for diagnosis over time reveal no change in the prevalence of depression. What has changed is the growing number of people who seek treatment for this condition, the increase in prescriptions for antidepressant medications, the number of articles about depression in the media and scientific literature, and the growing presence of depression as a phenomenon in popular culture. It is also true that epidemiological studies of the general population appear to reveal immense amounts of untreated depression. All of these changes lead to the perception that the disorder itself has become more common.

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