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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
Summary
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.
- 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.