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Psychosocial Outcomes Following Long-term, Double-blind Treatment of Chronic Depression With Sertraline vs Placebo
James H. Kocsis, MD;
Alan Schatzberg, MD;
A. John Rush, MD;
Daniel N. Klein, PhD;
Robert Howland, MD;
Leah Gniwesch, PhD;
Sonia M. Davis, DrPH;
Wilma Harrison, MD
Arch Gen Psychiatry. 2002;59:723-728.
Background Chronic forms of depression are associated with significant functional
and psychosocial impairments. To date, no study has measured psychosocial
functioning in this population during long-term maintenance antidepressant
treatment or following the double-blind discontinuation of treatment.
Methods Patients with chronic major or double depression completed 12 weeks
of short-term treatment followed by 16 weeks of continuation treatment with
sertraline hydrochloride. Responders at the end of the continuation phase
were randomized, double-blind, to 18 months of maintenance therapy with either
sertraline (n = 77) or placebo (n = 84). Multiple domains of psychosocial
functioning were assessed during double-blind therapy.
Results Substantial worsening in psychosocial function measures occurred in
patients taking placebo compared with sertraline during maintenance. Patients
with reemergence of depression lost psychosocial gains regardless of treatment.
In the subsample of patients who remained in remission throughout maintenance,
most of the observed improvement in psychosocial functioning occurred during
short-term treatment. By maintenance end point, normalization of functioning
was achieved by 58% to 84% of remitters, depending on the outcome measure
used.
Conclusions These results indicate that long-term treatment of chronic forms of
depression can result in sustained psychosocial benefits. Discontinuation
of treatment results in frequent reemergence of symptoms and loss of psychosocial
gains. Long-term treatment resulted in only modest further improvement of
psychosocial measures over that achieved in the short-term phase.
From the Cornell University School of Medicine, New York, NY (Drs Kocsis
and Gniwesch); Stanford University School of Medicine, Stanford, Calif (Dr
Schatzberg); University of Texas Southwestern Medical Center, Dallas (Dr Rush);
State University of New York at Stony Brook (Dr Klein); University of Pittsburgh
Medical Center and Western Psychiatric Institute and Clinic, Pittsburgh, Pa
(Dr Howland); Quintiles, Research Triangle Park, NC (Dr Davis); and Pfizer
Inc and College of Physicians and Surgeons, Columbia University, New York
(Dr Harrison).
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