Abstract | OBJECTIVE: 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:
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Authors | Joseph F Goldberg, Katherine E Burdick, Carrie J Endick |
Journal | The American journal of psychiatry
(Am J Psychiatry)
Vol. 161
Issue 3
Pg. 564-6
(Mar 2004)
ISSN: 0002-953X [Print] United States |
PMID | 14992985
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Anticonvulsants
- Antimanic Agents
- Benzothiazoles
- Dopamine Agonists
- Thiazoles
- Pramipexole
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Topics |
- Adult
- Ambulatory Care
- Anticonvulsants
(administration & dosage, adverse effects)
- Antimanic Agents
(administration & dosage, adverse effects)
- Benzothiazoles
- Bipolar Disorder
(diagnosis, drug therapy, psychology)
- Depressive Disorder, Major
(diagnosis, drug therapy, psychology)
- Dopamine Agonists
(administration & dosage, adverse effects)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Drug Resistance
- Drug Therapy, Combination
- Female
- Humans
- Male
- Middle Aged
- Personality Assessment
- Pilot Projects
- Pramipexole
- Thiazoles
(administration & dosage, adverse effects)
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