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Double-blind Switch Study of Imipramine or Sertraline Treatment of Antidepressant-Resistant Chronic Depression
Michael E. Thase, MD;
A. John Rush, MD;
Robert H. Howland, MD;
Susan G. Kornstein, MD;
James H. Kocsis, MD;
Alan J. Gelenberg, MD;
Alan F. Schatzberg, MD;
Lorrin M. Koran, MD;
Martin B. Keller, MD;
James M. Russell, MD;
Robert M. A. Hirschfeld, MD;
Lisa M. LaVange, PhD;
Daniel N. Klein, PhD;
Jan Fawcett, MD;
Wilma Harrison, MD
Arch Gen Psychiatry. 2002;59:233-239.
Background Although various strategies have been proposed to treat antidepressant
nonresponders, little controlled research has been published that examines
prospectively the use of switching to an alternate antidepressant.
Methods This was a multisite study in which outpatients with chronic major depression
(with or without concurrent dysthymia), who failed to respond to 12 weeks
of double-blind treatment with either sertraline hydrochloride (n = 117) or
imipramine hydrochloride (n = 51), were crossed over or switched to 12 additional
weeks of double-blind treatment with the alternate medication. Outcome measures
included the 24-item Hamilton Rating Scale for Depression and the Clinical
Global Impressions–Severity and Improvement scales.
Results The switch from sertraline to imipramine (mean dosage, 221 mg/d) and
from imipramine to sertraline (mean dosage, 163 mg/d) resulted in clinically
and statistically significant improvements. The switch to sertraline treatment
was associated with fewer adverse effect complaints and significantly less
attrition owing to adverse effects. Although sertraline treatment also resulted
in significantly higher response rates in the intent-to-treat samples (60%
in the sertraline group and 44% in the imipramine group), neither the intent-to-treat
remission rates nor the response and remission rates among study completers
differed significantly. Moreover, after considering the effect of attrition,
there were no significant treatment effects on the more comprehensive generalized
estimating equation analyses of the continuous dependent measures.
Conclusions More than 50% of chronically depressed antidepressant nonresponders
benefited from a switch from imipramine to sertraline, or vice versa, despite
a high degree of chronicity. As in the initial trial, sertraline was generally
better tolerated than imipramine. Switching to a standard antidepressant of
a different class is a useful treatment strategy for antidepressant nonresponders
and could be considered a standard of comparison for future studies of novel
alternate strategies.
From the Departments of Psychiatry, University of Pittsburgh School
of Medicine, and Western Psychiatric Institute and Clinic, Pittsburgh, Pa
(Drs Thase and Howland), The University of Texas Southwestern Medical Center
at Dallas (Dr Rush), Medical College of Virginia, Virginia Commonwealth University,
Richmond (Dr Kornstein), Cornell University School of Medicine, New York,
NY (Dr Kocsis), University of Arizona, Tucson (Dr Gelenberg), Stanford University
School of Medicine, Stanford, Calif (Drs Schatzberg and Koran), Butler Hospital,
Brown University, Providence, RI (Dr Keller), and The University of Texas
Medical Branch at Galveston (Drs Russell and Hirschfeld); Quintiles, Inc,
Research Triangle Park, North Carolina (Dr LaVange); Departments of Psychiatry,
State University of New York at Stony Brook (Dr Klein), and Rush-Presbyterian-St
Luke's Medical Center, Chicago, Ill (Dr Fawcett); Pfizer Inc and Department
of Psychiatry, College of Physicians and Surgeons, Columbia University, New
York (Dr Harrison). The following authors have served as paid consultants
to these companies: Pfizer Inc (Drs Thase, Rush, Kornstein, Kocsis, Gelenberg,
Schatzberg, Koran, Keller, Russell, Hirschfeld, LaVange, and Fawcett) and
Abbott Laboratories, North Chicago, Ill (Drs Hirschfeld and Fawcett). Drs
Kocsis, Gelenberg, and Harrison own stock in Pfizer Inc.
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