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A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder.

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Date
2013-07
Authors
Cusin, Cristina
Iovieno, Nadia
Iosifescu, Dan V
Nierenberg, Andrew A
Fava, Maurizio
Rush, A John
Perlis, Roy H
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Abstract
<h4>Background</h4>Multiple treatments for patients with major depressive disorder (MDD) have demonstrated efficacy, but up to one-third of individuals with MDD do not achieve symptomatic remission despite various interventions. Existing augmentation or combination strategies can have substantial safety concerns that may limit their application.<h4>Method</h4>This study investigated the antidepressant efficacy of a flexible dose of the dopamine agonist pramipexole as an adjunct to standard antidepressant treatment in an 8-week, randomized, double-blind, placebo-controlled trial conducted in a tertiary-level depression center. We randomized 60 outpatients (aged 18 to 75 years) with treatment-resistant nonpsychotic MDD (diagnosed according to DSM-IV) to either pramipexole (n = 30) or placebo (n = 30). Treatment resistance was defined as continued depression (Montgomery-Asberg Depression Rating Scale [MADRS] score ≥ 18) despite treatment with at least 1 prior antidepressant in the current depressive episode. Patients were recruited between September 2005 and April 2008. The primary outcome measure was the MADRS score.<h4>Results</h4>The analyses that used a mixed-effects linear regression model indicated a modest but statistically significant benefit for pramipexole (P = .038). The last-observation-carried-forward analyses indicated that 40% and 33% of patients randomized to augmentation with pramipexole achieved response (χ(2) = 1.2, P = .27) and remission (χ(2) = 0.74, P = .61), respectively, compared to 27% and 23% with placebo; however, those differences were not statistically significant. Augmentation with pramipexole was well-tolerated, with no serious adverse effects identified.<h4>Conclusion</h4>For patients who have failed to respond to standard antidepressant therapies, pramipexole is a safe and potentially efficacious augmentation strategy.<h4>Trial registration</h4>ClinicalTrials.gov identifier: NCT00231959.
Type
Journal article
Subject
Humans
Dopamine Agonists
Antidepressive Agents
Drug Monitoring
Treatment Outcome
Drug Therapy, Combination
Remission Induction
Double-Blind Method
Depressive Disorder, Major
Psychiatric Status Rating Scales
Dose-Response Relationship, Drug
Drug Synergism
Diagnostic and Statistical Manual of Mental Disorders
Adult
Aged
Middle Aged
Female
Male
Benzothiazoles
Depressive Disorder, Treatment-Resistant
Pramipexole
Permalink
https://hdl.handle.net/10161/24821
Published Version (Please cite this version)
10.4088/jcp.12m08093
Publication Info
Cusin, Cristina; Iovieno, Nadia; Iosifescu, Dan V; Nierenberg, Andrew A; Fava, Maurizio; Rush, A John; & Perlis, Roy H (2013). A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder. The Journal of clinical psychiatry, 74(7). pp. e636-e641. 10.4088/jcp.12m08093. Retrieved from https://hdl.handle.net/10161/24821.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Augustus John Rush

Adjunct Professor in the Department of Psychiatry and Behavioral Sciences
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