Pramipexole for stage 2 treatment-resistant major depression: An open study

Objective: To examine the effectiveness and safety of adjunctive pramipexole in the treatment of stage 2 treatment-resistant major depressive disorder. Methods: This study included patients with moderate or non-psychotic severe major depressive disorder according to DSM-IV-TR criteria despite at least two adequate treatment trials with antidepressants from different pharmacological classes. Pramipexole 0.25 to 2 mg daily was added to antidepressant therapy. Previous treatments were continued unchanged, but no new treatments were allowed. We conducted assessments at baseline and at weeks 2, 4, 6, and 8. We defined response as a 50% or greater reduction on the Montgomery-Asberg Depression Rating Scale (MADRS). Results: Ten patients (4 men, 6 women) aged 43.7 +/- 11.4 years received pramipexole at mean dose of 1.3 +/- 0.6 mg/d. Mean MADRS scores improved significantly from baseline to endpoint (mean differences = 11.4, 95% CI [4.1, 18.7], P = 0.0064). At the endpoint, six of 10 (60%) were responders on MADRS (>= 50% reduction). Two patients (20%) terminated early due to mild somatic and psychiatric adverse effects. Conclusion: These preliminary data suggest that the addition of pramipexole to antidepressant treatment may be effective and well tolerated in patients with stage 2 treatment-resistant major depressive disorder. (C) 2010 Elsevier Inc. All rights reserved.