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Related Experiment Videos

Methodologic issues in maintenance therapy clinical trials.

J B Greenhouse1, D Stangl, D J Kupfer

  • 1Department of Statistics, Carnegie Mellon University, Pittsburgh, PA 15213-3890.

Archives of General Psychiatry
|April 1, 1991
PubMed
Summary
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Reanalyzing a 1980s trial on unipolar disorder reveals that earlier conclusions about imipramine and combination therapy

Area of Science:

  • Psychiatry
  • Clinical Psychology
  • Pharmacology

Background:

  • A 1980s multicenter trial evaluated lithium, imipramine, combination therapy, and placebo for affective disorder recurrence.
  • The original study focused on both unipolar and bipolar disorder patients.

Purpose of the Study:

  • To reanalyze the efficacy of treatments for unipolar disorder.
  • To examine general issues in the design and conduct of maintenance therapy trials.

Main Methods:

  • Reanalysis of a randomized, controlled clinical trial.
  • Focus on patients with unipolar disorder.

Main Results:

  • Earlier conclusions favoring imipramine and combination therapy may be due to study design.

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  • Alternative explanations exist for the observed treatment differences.

    • Conclusions:

    • Findings impact the design, conduct, and interpretation of maintenance therapy trials.
    • Critically evaluate study design in affective disorder treatment research.