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Pramipexole May Be Effective Adjunct to Antidepressant Treatment
A DGReview of :"Pramipexole in treatment-resistant depression: a 16-week naturalistic study."
Bipolar Disorders
12/27/2002
By Elda Hauschildt
Pramipexole may be effective and well tolerated as an adjunct to antidepressant therapy for resistant major depression, Italian researchers suggest.
Investigators from the University of Pisa in Pisa enrolled 37 drug-resistant inpatients who had a major depressive episode as diagnosed by Diagnostic and Statistical Manual for Mental Disorders - IV criteria. Treatment included tricyclic antidepressants or serotonin reuptake inhibitors.
Pramipexole was added to therapy at doses from 0.375 mg/day to 1.0 mg/day.
Sixteen participants had unipolar depression and 21 had bipolar depression. Study analyses excluded six patients who dropped out in the first week; 19 of the 31 patients included in the study completed the 16-week follow up period.
Response criteria at end point included a greater than 50 percent reduction in total score for the Montgomery-Asberg Depressive Rating Scale (MADRS) and a Clinical Global Impression (CGI-1) scale score of 1 or 2.
The mean maximal pramipexole dose used was 0.95 mg/day. Mean MADRS scores decreased to 13.9 at end point from 33.3 at baseline (p < 0.001). Mean CGI-1 decreased to 2.8 at end point from 4.6 at baseline (p < 0.001).
"At end point, 67.7 percent of patients (21 of 31) were responders on MADRS and 74.2 percent on CGI-1," the researchers write.
A total of 10 of the 37 enrolled patients discontinued pramipexole therapy because of adverse events.
Bipolar Disorders, 2002; 4: 307-314.
"Pramipexole in treatment-resistant depression: a 16-week naturalistic study."
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