Initial results help clinicians identify patients with treatment-resistant depression

Initial results of the nation's largest clinical trial for depression have helped clinicians to track "real world" patients who became symptom-free and to identify those who were resistant to the initial treatment. Participants treated in both medical and specialty mental health care settings experienced a remission of symptoms in 12 to 14 weeks during well-monitored treatment with an antidepressant medication. The study, funded by the National Institutes of Health's (NIH) National Institute of Mental Health (NIMH), used flexible adjustment of dosages based on quick and easy-to-use clinician ratings of symptoms and patient self-ratings of side effects.

About a third of participants reached a remission or virtual absence of symptoms during the initial phase of the study, with an additional 10 to 15 percent experiencing some improvement. Subsequent phases of the trials will help determine successful treatments for the nearly two thirds of those patients who were identified as treatment-resistant to a first medication in phase one.

The trial, known as the STAR*D study -- Sequenced Treatment Alternatives to Relieve Depression -- included 2,876 participants and was conducted over six years at a cost of $35 million. (For more information on STAR*D, go to: http://www.clinicaltrials.gov/ct/show/NCT00021528?order=1).

The medication used in this first phase of the study was the serotonin reuptake inhibitor (SSRI) citalopram (Celexa, made by Forest Pharmaceuticals), and response rates were comparable across the 23 psychiatric and 18 primary care treatment sites. John Rush, M.D., and Madhukar Trivedi, M.D., of the University of Texas Southwestern Medical Center (UTSMC), and colleagues report on the results of phase 1 of STAR*D in the January, 2005 American Journal of Psychiatry.

"The real goal of STAR*D is how best to help the 70 percent of patients for whom treatmen

Contact: Jules Asher
NIH/National Institute of Mental Health

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