STAR^*D Findings May Guide Treatment Recommendations

One-third of patients with major depression who take an adequate dose of an SSRI antidepressant for a sufficient period can expect to achieve full remission of their depression, a new government report says. An additional 10 percent to 15 percent of patients can expect significant improvement, short of remission.

The findings are from the first phase of data from the largest medication treatment trial for major depression undertaken to date. Known as STAR^*D (Sequenced Treatment Alternatives to Relieve Depression), the study included 2,876 patients with major depressive disorder. The $35 million, six-year protocol involving researchers and clinicians at 23 psychiatric and 18 primary care treatment sites across the country is being funded by the National Institute of Mental Health. The results of the first phase of the four-phase trial were published in the January American Journal of Psychiatry.

STAR^*D was designed to help determine the most effective treatment strategies for major depressive disorder by focusing on“ real-world” patients with depression. The four phases of the trial are geared toward shedding light on how best to treat individuals who do not respond to the first antidepressant tried.

“STAR^*D is important because it represents the largest group of moderately to severely depressed patients studied, most of whom had either chronic or recurrent major depression, and the majority of whom also had concurrent other general medical or psychiatric disorders,” said A. John Rush, M.D., vice chair of research in psychiatry at the University of Texas Southwestern Medical Center and STAR^*D's principal investigator, in a press release. “What is also important is that nearly half of these patients significantly benefited from and showed a response to the medications, with 1 in 3 achieving a symptom-free state after the first round of medication.”

“In the field of depression treatment, the burning question is, `What are the best approaches for treatment of depression, and, more importantly, what are the next subsequent steps to take if the first step doesn't lead to full remission?” added Madhukar Trivedi, M.D., in a press release. Trivedi is a professor of psychiatry also at the University of Texas Southwestern Medical Center and the lead author of last month's report.

What sets STAR^*D apart from other studies of depression treatment, Trivedi continued, is that “we entered into the community of practitioners who were not doing research studies themselves, but were routinely treating patients with depression—both in primary care and specialty care.”

Rather than evaluating the effects of standardized treatment protocols on individuals who volunteer for clinical studies—such as those conducted for Food and Drug Administration approvals of medications—the patients in STAR^*D “were already being treated for depression,” and many had multiple other medical illnesses, as well as psychiatric comorbidities. “The results from this study can thus easily be transferred to routine clinical practice in both primary and specialty care.”