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

ObjectiveTo examine the effectiveness and safety of adjunctive pramipexole in the treatment of stage 2 treatment-resistant major depressive disorder.MethodsThis 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–Åsberg Depression Rating Scale (MADRS).ResultsTen 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.ConclusionThese 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.

Research Highlights
► Treatment-resistant major depression (TRD) is a major issue in clinical practice.
► Adjunctive pramipexole, a dopamine agonist, is reportedly effective for stage 1 TRD.
► This study examined the effectiveness of adjunctive pramipexole in stage 2 TRD.
► The addition of pramipexole to antidepressant improved depression in stage 2 TRD.
► Pramipexole was well tolerated in patients.