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

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2013-07

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Abstract

Background

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.

Method

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.

Results

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.

Conclusion

For patients who have failed to respond to standard antidepressant therapies, pramipexole is a safe and potentially efficacious augmentation strategy.

Trial registration

ClinicalTrials.gov identifier: NCT00231959.

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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

Citation

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https://hdl.handle.net/10161/24821

Published Version (Please cite this version)

10.4088/jcp.12m08093

Publication Info

Cusin, Cristina, Nadia Iovieno, Dan V Iosifescu, Andrew A Nierenberg, Maurizio Fava, A John Rush and Roy H Perlis (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.

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