A double-blind, randomized, controlled trial of fluoxetine plus quetiapine or clomipramine versus fluoxetine plus placebo for obsessive-compulsive disorder.
Abstract
Obsessive-compulsive disorder patients who do not improve sufficiently after treatment with a selective serotonin reuptake inhibitor might improve further if other drugs were added to the treatment regimen. The authors present a double-blind, placebo-controlled trial comparing the efficacy of adding quetiapine or clomipramine to a treatment regimen consisting of fluoxetine. Between May 2007 and March 2010, a total of 54 patients with a primary diagnosis of obsessive-compulsive disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, and a current Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of at least 16, the score having dropped by less than 35% after fluoxetine monotherapy, were allocated to 1 of 3 arms (n = 18 per arm): quetiapine + fluoxetine (≤200 and ≤40 mg/d, respectively), clomipramine + fluoxetine (≤75 and ≤40 mg/d, respectively), or placebo + fluoxetine (≤80 mg/d of fluoxetine). Follow-up was 12 weeks. The Y-BOCS scores were the main outcome measure. No severe adverse events occurred during the trial, and 40 patients (74%) completed the 12-week protocol. The Y-BOCS scores (mean [SD]) were significantly better in the placebo + fluoxetine and clomipramine + fluoxetine groups than in the quetiapine + fluoxetine group (final: 18 [7] and 18 [7], respectively, vs 25 [6], P < 0.001) (reduction from baseline: -6.7 [confidence interval {CI}, -9.6 to -3.8; and -6.5 [CI, -9.0 to -3.9], respectively, vs -0.1 [CI, -2.9 to 2.7], P < 0.001; number needed to treat = 2.4). The clomipramine-fluoxetine combination is a safe and effective treatment for fluoxetine nonresponders, especially those who cannot tolerate high doses of fluoxetine. However, the period of monotherapy with the maximum dose of fluoxetine should be extended before a combination treatment strategy is applied.
Links
Authors
Diniz JB, Shavitt RG, Fossaluza V, Koran L, Pereira CA, Miguel EC
Institution
Department & Institute of Psychiatry, Hospital das Clínicas, University of São Paulo School of Medicine, University of São Paulo, São Paulo, SP, Brazil. julianabelo.diniz@gmail.com
Source
Journal of clinical psychopharmacology 31:6 2011 Dec pg 763-8MeSH
AdolescentAdult
Antipsychotic Agents
Clomipramine
Dibenzothiazepines
Double-Blind Method
Drug Therapy, Combination
Fluoxetine
Follow-Up Studies
Humans
Middle Aged
Obsessive-Compulsive Disorder
Serotonin Uptake Inhibitors
Treatment Outcome
Young Adult
Pub Type(s)
Comparative StudyJournal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Language
eng
PubMed ID
22020357
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