Tags

Type your tag names separated by a space and hit enter

Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression.
Am J Psychiatry 2004; 161(3):564-6AJ

Abstract

OBJECTIVE

Previous studies suggest that the dopamine agonist pramipexole may possess antidepressant properties. The authors conducted a preliminary randomized, placebo-controlled trial to determine the safety and antidepressant efficacy of pramipexole in treatment-resistant bipolar depression.

METHOD

Twenty-two depressed outpatients with DSM-IV nonpsychotic bipolar disorder were randomly assigned to receive placebo or flexibly dosed pramipexole (mean maximum dose=1.7 mg/day, SD=1.3) added to existing mood stabilizers for 6 weeks. The primary outcome measure was response, defined as improvement in Hamilton Depression Rating Scale score of 50% or more over the baseline score; secondary analyses involved changes in Clinical Global Impression (CGI) severity scores.

RESULTS

More patients given pramipexole (10 [83%] of 12) than patients given placebo (six [60%] of 10) completed the study. Eight (67%) of 12 patients taking pramipexole and two (20%) of 10 taking placebo had an improvement of at least 50% in their Hamilton depression scale scores. The mean percentage of improvement from baseline Hamilton depression scale scores was greater for patients taking pramipexole (48%) than for those taking placebo (21%). Mean improvements in CGI severity were also greater with pramipexole than placebo. No patients discontinued the study because of adverse events except for one patient who became hypomanic while taking pramipexole.

CONCLUSIONS

Pramipexole was a safe and effective antidepressant among patients with bipolar depression. Larger randomized, controlled trials are needed to affirm these initial observations.

Authors+Show Affiliations

Department of Psychiatry, Weill Medical College of Cornell University, New York, NY, USA. jgoldber1@lij.eduNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

14992985

Citation

Goldberg, Joseph F., et al. "Preliminary Randomized, Double-blind, Placebo-controlled Trial of Pramipexole Added to Mood Stabilizers for Treatment-resistant Bipolar Depression." The American Journal of Psychiatry, vol. 161, no. 3, 2004, pp. 564-6.
Goldberg JF, Burdick KE, Endick CJ. Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression. Am J Psychiatry. 2004;161(3):564-6.
Goldberg, J. F., Burdick, K. E., & Endick, C. J. (2004). Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression. The American Journal of Psychiatry, 161(3), pp. 564-6.
Goldberg JF, Burdick KE, Endick CJ. Preliminary Randomized, Double-blind, Placebo-controlled Trial of Pramipexole Added to Mood Stabilizers for Treatment-resistant Bipolar Depression. Am J Psychiatry. 2004;161(3):564-6. PubMed PMID: 14992985.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression. AU - Goldberg,Joseph F, AU - Burdick,Katherine E, AU - Endick,Carrie J, PY - 2004/3/3/pubmed PY - 2004/4/20/medline PY - 2004/3/3/entrez SP - 564 EP - 6 JF - The American journal of psychiatry JO - Am J Psychiatry VL - 161 IS - 3 N2 - OBJECTIVE: Previous studies suggest that the dopamine agonist pramipexole may possess antidepressant properties. The authors conducted a preliminary randomized, placebo-controlled trial to determine the safety and antidepressant efficacy of pramipexole in treatment-resistant bipolar depression. METHOD: Twenty-two depressed outpatients with DSM-IV nonpsychotic bipolar disorder were randomly assigned to receive placebo or flexibly dosed pramipexole (mean maximum dose=1.7 mg/day, SD=1.3) added to existing mood stabilizers for 6 weeks. The primary outcome measure was response, defined as improvement in Hamilton Depression Rating Scale score of 50% or more over the baseline score; secondary analyses involved changes in Clinical Global Impression (CGI) severity scores. RESULTS: More patients given pramipexole (10 [83%] of 12) than patients given placebo (six [60%] of 10) completed the study. Eight (67%) of 12 patients taking pramipexole and two (20%) of 10 taking placebo had an improvement of at least 50% in their Hamilton depression scale scores. The mean percentage of improvement from baseline Hamilton depression scale scores was greater for patients taking pramipexole (48%) than for those taking placebo (21%). Mean improvements in CGI severity were also greater with pramipexole than placebo. No patients discontinued the study because of adverse events except for one patient who became hypomanic while taking pramipexole. CONCLUSIONS: Pramipexole was a safe and effective antidepressant among patients with bipolar depression. Larger randomized, controlled trials are needed to affirm these initial observations. SN - 0002-953X UR - https://www.unboundmedicine.com/medline/citation/14992985/Preliminary_randomized_double_blind_placebo_controlled_trial_of_pramipexole_added_to_mood_stabilizers_for_treatment_resistant_bipolar_depression_ L2 - https://ajp.psychiatryonline.org/doi/full/10.1176/appi.ajp.161.3.564?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -