Imipramine Is Effective in Preventing Relapse in Electroconvulsive Therapy-Responsive Depressed Inpatients With Prior Pharmacotherapy Treatment Failure: A Randomized, Placebo-Controlled Trial
J Clin Psychiatry 2006;67(2):263-268
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Objective: To compare the efficacy of
imipramine versus placebo in preventing relapse after
successful electroconvulsive therapy (ECT) in
depressive inpatients with pharmacotherapy
treatment failure prior to ECT.
Method: During a 6-month period, the
incidence of relapse was assessed. Two centers, both
inpatient units for treatment of depressed patients,
participated in this trial. Patients with
DSM-IV-diagnosed major depressive disorder resistant to an
antidepressant and subsequent lithium addition and/or
a monoamine oxidase inhibitor were included. Patients were randomly assigned to
double-blind treatment with imipramine with adequate
plasma levels (N = 12) or placebo (N = 15) after
successful ECT. The mean imipramine dosage was 209
mg/day (standard deviation: 91.7, range: 75 - 325 mg/day). The main outcome measure was relapse
defined as at least "moderately worse" compared
with baseline score on the Clinical Global
Impressions-Improvement scale. Treatments were
compared with survival analysis using the Cox
proportional hazards model, including psychotic features and
the score on the Hamilton Rating Scale for
Depression (HAM-D) at baseline as prespecified
covariables. Patients were enrolled in the study from April
1997 to July 2001.
Results: In the placebo group, 80% (12/15)
of the patients relapsed compared with 18% (2/11)
in the imipramine group. The Cox regression
analysis showed a significant reduction in the risk of
relapse of 85.6% with imipramine compared to
placebo (p = .007; 95% confidence interval [CI] = 24.6%
to 97.2%) adjusted for the covariables. There was
an 18% increase in the relapse rate (p = .032; 95% CI = 2% to 36%) per unit increase in HAM-D
score before the start of the trial; psychotic features
had no significant effect (p = .794).
Conclusions: Depressed patients with
pharmacotherapy treatment failure may benefit from
the prophylactic effect of the same class of drug
during maintenance therapy after response to ECT.