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National Institutes of Health

Science Update
December 21, 2006

Landmark Council Session Spotlights “Real World” Trials

Principal investigators of NIMH's four large-scale clinical trials presented study results and their implications at the National Advisory Mental Health Council meeting on September 15, 2006. Stephen Hyman, MD, who launched the trials during his tenure as NIMH Director, presented background and context for the trials, which evaluated various treatments for schizophrenia, depression, and bipolar disorder.

Presentations can be viewed in the VideoCasts below.

The trials — the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study, the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE), the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), and the Treatments for Adolescents with Depression Study (TADS) — examined the effectiveness of treatments in commonplace situations.

Whereas most treatment studies usually exclude potential participants with co-existing medical illnesses, drug or alcohol addiction, or a co-occurring mental illness, these large trials embraced participants with these characteristics in order to better replicate conditions that are common in actual clinical practice. Rather than using a placebo for reference, treatments were compared directly. This allowed researchers to determine the effectiveness of various treatment methods in relation to one another. In addition to clinical effectiveness, the studies also examined the cost-effectiveness of various treatment methods.

The NIMH-sponsored effectiveness trials offered an alternative to traditional industry-backed trial methods by focusing on functional status and the patient's level of disability rather than short-term changes in symptoms. Participants were followed over many months, as opposed to several weeks, allowing investigators to determine the long-term success of varying treatment methods. The trials also differed from more traditional studies in terms of scale, utilizing multiple sites and community-relevant populations to better replicate the diversity of real world treatment scenarios. Over the course of the trials, researchers concentrated on minimizing the impact of the disorders on everyday life, allowing participants to return to work, school and other activities.

"These trials address a pressing public health problem," stated former NIMH Director Dr. Stephen Hyman, "to use the treatments we have as well as we can."

Speakers included Jeffrey Lieberman (CATIE), Gary Sachs (STEP-BD), John March (TADS) and John Rush (STAR*D) and Council member Susan Essock. Videos of each talk follow (requires RealPlayer):

The NIMH Clinical Trials Program: Major Findings and Implications for Everyday Practice

Date: Friday, September 15, 2006 (Open Policy Session of the National Advisory Mental Health Council)

Speaker: Steven E. Hyman, M.D.
Provost, Harvard University
Background and Context for the Program

Speaker: Jeffrey Lieberman, M.D.
Director, New York State Psychiatric Institute; Chairman and Lieber Professor of Psychiatry, Department of Psychiatry, Columbia University Medical Center
Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)

Speaker: Gary Sachs, M.D.
Director, Bipolar Clinical and Research Program, Massachusetts General Hospital; Associate Professor of Psychiatry, Harvard Medical School
Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD)

Speaker: John March, M.D., MPH
Professor of Psychiatry & Chief, Child and Adolescent Psychiatry, Department of psychiatry and Behavioral Sciences, Duke University Medical Center
Treatment for Adolescents with Depression Study (TADS)

Speaker: A. John Rush, M.D.
Rosewood Corporation Chair in Biomedical Science & Betty Jo Hay Distinguished Chair in Mental Health, Department of Clinical Sciences, University of Texas Southwestern Medical Center at Dallas
Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

Speaker: Susan M. Essock, Ph.D.
Professor & Director, Division of Health Services Research, Mount Sinai School of Medicine
Next Steps in Determining Optimal Care