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A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder.
J Clin Psychiatry 2013; 74(7):e636-41JC

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.

Authors+Show Affiliations

Depression Clinical and Research Program, Massachusetts General Hospital, One Bowdoin Square, Ste 630, Boston, MA 02114, USA. ccusin@partners.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

23945458

Citation

Cusin, Cristina, et al. "A Randomized, Double-blind, Placebo-controlled Trial of Pramipexole Augmentation in Treatment-resistant Major Depressive Disorder." The Journal of Clinical Psychiatry, vol. 74, no. 7, 2013, pp. e636-41.
Cusin C, Iovieno N, Iosifescu DV, et al. A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder. J Clin Psychiatry. 2013;74(7):e636-41.
Cusin, C., Iovieno, N., Iosifescu, D. V., Nierenberg, A. A., Fava, M., Rush, A. J., & Perlis, R. 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. e636-41. doi:10.4088/JCP.12m08093.
Cusin C, et al. A Randomized, Double-blind, Placebo-controlled Trial of Pramipexole Augmentation in Treatment-resistant Major Depressive Disorder. J Clin Psychiatry. 2013;74(7):e636-41. PubMed PMID: 23945458.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder. AU - Cusin,Cristina, AU - Iovieno,Nadia, AU - Iosifescu,Dan V, AU - Nierenberg,Andrew A, AU - Fava,Maurizio, AU - Rush,A John, AU - Perlis,Roy H, PY - 2012/08/13/received PY - 2012/12/17/accepted PY - 2013/8/16/entrez PY - 2013/8/16/pubmed PY - 2013/11/2/medline SP - e636 EP - 41 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 74 IS - 7 N2 - 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. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/23945458/A_randomized_double_blind_placebo_controlled_trial_of_pramipexole_augmentation_in_treatment_resistant_major_depressive_disorder_ L2 - http://www.psychiatrist.com/jcp/article/pages/2013/v74n07/v74n0702.aspx DB - PRIME DP - Unbound Medicine ER -