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NIMH Studies Advance Research Base

April 2006

Two clinical studies funded by the National Institute of Mental Health (NIMH) were released recently, both within a week of opening day of the baseball season. The studies advance significantly the research base for treatment of mental illnesses.

Like America's favorite pastime, it's hard to follow the research game without a scorecard.

Known as STAR*D2 and CATIE II, the studies focused on depression and schizophrenia, and are part of the "Big Four" research initiatives that also include STEP-BD for bipolar disorder and TADS for adolescent depression. The acronyms are more colorful than the actual names.

  • STAR*D is Sequenced Treatment Alternatives to Relieve Depression
  • CATIE is Clinical Antipsychotic Trials of Intervention Effectiveness
  • STEP-BD is Systematic Treatment Enhancement Program for Bipolar Disorder
  • TADS isTreatment for Adolescent Depression Study

One can only wonder what Yogi Berra might say.

Names and baseball aside, the studies are important because unlike clinical trials conducted by private industry, their focus is longer and comparative in nature and involves what NAMI medical director Ken Duckworth calls "real world" conditions. They provide key "building blocks" for a public research "infrastructure" that can lead to newer, better medications.

The most recent installment of STAR*D found that one in three consumers (33%) whose depression was resistant to initial treatment were able to achieve remission   -- becoming not just better, but symptom-free -- when a second medication was added. One in four (25%) achieved remission after switching to a different antidepressant.

The study delivered a clear message of hope: People do get better, to the point of complete remission, as long as they keep trying.

It demonstrated reasonable alternative strategies for doctors and consumers when one medication doesn't work.

STAR*D2 also underscores the importance of healthcare plans and state Medicaid programs preserving access to a range of medications: Limiting choices to only two or three antidepressants will condemn too many individuals to life-threatening illness.

Similarly, the latest installment of CATIE provided important evidence about choices in the treatment of schizophrenia. Different individuals respond differently to different drugs. Like the antidepressants in STAR*D2, if one antipsychotic medication is not fully effective in treating schizophrenia, the study provides guidance to doctors and consumers about switching to or adding a second drug.

The studies provide evidence on which further research can be built. In some cases, the studies raise more questions, rather than answers, particularly in the area of side effects. More research is needed, but it's also clear that simply comparing existing pharmaceutical compounds isn't a solution. Greater vision drives research.

"There is critical need for a new generation of research that will produce a new generation of medications," said NAMI executive director Michael J. Fitzpatrick. "We need more effective medication choices with fewer or no side effects. Existing medications benefit many people, but there are still many who continue to struggle with symptoms despite what they take. Others experience side effects so serious that they ultimately choose to stop treatment."

More information about these studies can be found on the Web.

NIMH Press Release on StarD*2

NAMI Talking Points on STAR*D2

NIMH Press Release on CATIE II

More NAMI Background on CATIE Studies

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