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What should a physician do when a patient with major depressive disorder (MDD) does not respond to his or her first treatment with an antidepressant? What are the ramifications of switching medications or of augmenting the current medication with another?

Answering these questions was the goal of the National Institute of Mental Health's (NIMH) program known as STAR*D, or Sequenced Treatment Alternatives to Relieve Depression.

Dr. Grayson Norquist, chair of the Department of Psychiatry at the University of Mississippi Medical Center (UMC) and former director of the division at NIMH that launched the study, said, "Eight years ago, we reminded ourselves that we work for the public, not the FDA. We decided to work on a way to offer relevant trials for clinical practitioners."

Using a study design that mimics conditions found in actual clinical settings, STAR*D, which enrolled over 4,000 patients aged 18 to 75 over a seven-year period, is "the largest and longest study to ever done to evaluate depression treatment," according to an NIMH Q&A brochure.

Norquist said, "Until this study, the only evidence we had was basically that using an antidepressant was better than using nothing. But the question was, 'If the antidepressant doesn't work, what do you do next?'"

Though the results of the trial are still coming in and the data are still being evaluated, the outcome so far looks promising. According to an NIMH press release, "During Levels 1 and 2 of the STAR*D trial ... about half of all patients became symptom-free. Of the other half, about one in five became symptom-free when they went on to Level 3 and switched medications again."

As Norquist put it, "The basic message with STAR*D is that if you are out there in clinical practice and a patient is not responding well to initial treatment, then you can switch to another medication or augment the current treatment, and there is a good chance the patient will get better."

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