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Use of Pattern Analysis to Predict Differential Relapse of Remitted Patients With Major Depression During 1 Year of Treatment With Fluoxetine or Placebo
Jonathan W. Stewart, MD;
Frederic M. Quitkin, MD;
Patrick J. McGrath, MD;
Jay Amsterdam, MD;
Maurizio Fava, MD;
Jan Fawcett, MD;
Frederick Reimherr, MD;
Jerrold Rosenbaum, MD;
Charles Beasley, MD;
Paul Roback, MS
Arch Gen Psychiatry. 1998;55:334-343.
Background Delayed and persistent ("true drug") improvement characterizes the response to antidepressant medication. Early or nonpersistent ("placebo") benefit is typical of a placebo response. The prediction was that patients with a true drug response would sustain their benefit best if they continued to receive the drug and that patients with a placebo response would have an equivalent prognosis whether they continued to receive the drug or were switched to placebo.
Methods Patients with major depression who met the study's response criteria (a modified Hamilton Depression Rating Scale score  7 and failure to meet major depression criteria after each of the last 3 weeks following 12 to 14 weeks of treatment with fluoxetine hydrochloride, 20 mg/d) were enrolled in a 50-week randomized placebo substitution trial during which the return of depressive symptoms defined relapse. The timing and persistency of response during initial treatment defined true drug or placebo response patterns.
Results Patients with a true drug response pattern relapsed significantly more frequently if they were switched to placebo than if they continued to receive fluoxetine (P<.001 for weeks 12-26, P<.005 for weeks 26-50, and P<.41 for weeks 50-62). Patients with a placebo response pattern had an equivalent outcome whether maintained on fluoxetine therapy or placebo (P<.20 for weeks 12-26, test invalid for weeks 26-50, and P <.67 for weeks 50-62). Patients with a placebo response pattern relapsed more often when they continued to receive fluoxetine than patients with a true drug response pattern (P<.01 for weeks 12-26, P<.10 for weeks 26-50, and P<.36 for weeks 50-62).
Conclusions These findings confirm that pattern analysis validly differentiates true drug from nonspecific initial responses and extend its use to the continuation and maintenance phases of treatment for depression. Investigations into the mechanisms of antidepressant activity might best be limited to those that can account for delayed efficacy. Fluoxetine's efficacy during the continuation and maintenance phases of treatment may be limited to patients with a true drug pattern of initial response.
From the Department of Psychiatry, New York State Psychiatric Institute, New York (Drs Stewart, Quitkin, and McGrath); Department of Psychiatry, University of Pennsylvania, Philadelphia (Dr Amsterdam); Department of Psychiatry, Massachusetts General Hospital, Boston (Drs Fava and Rosenbaum); Department of Psychiatry, Rush-Presbyterian St Luke's Medical Center, Chicago, Ill (Dr Fawcett); Department of Psychiatry, University of Utah, Salt Lake City (Dr Reimherr); Eli Lilly Corporation, Indianapolis, Ind (Dr Beasley); and Department of Statistics, Colorado State University, Fort Collins (Mr Roback).
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