Premium
Pramipexole in treatment‐resistant depression: a 16‐week naturalistic study
Author(s) -
Lattanzi Lorenzo,
Dell'Osso Liliana,
Cassano Paolo,
Pini Stefano,
Rucci Paola,
Houck Patricia R,
Gemignani Alfredo,
Battistini Giulia,
Bassi Annalisa,
Abelli Marianna,
Cassano Giovanni B
Publication year - 2002
Publication title -
bipolar disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.285
H-Index - 129
eISSN - 1399-5618
pISSN - 1398-5647
DOI - 10.1034/j.1399-5618.2002.01171.x
Subject(s) - pramipexole , tolerability , clinical global impression , medicine , antidepressant , psychology , depression (economics) , clinical endpoint , adverse effect , bipolar disorder , treatment resistant depression , rating scale , clinical trial , placebo , parkinson's disease , developmental psychology , alternative medicine , disease , pathology , lithium (medication) , hippocampus , economics , macroeconomics
Lattanzi L, Dell'Osso L, Cassano P, Pini S, Rucci P, Houck PR, Gemignani A, Battistini G, Bassi A, Abelli M, Cassano GB. Pramipexole in treatment‐resistant depression: a 16‐week naturalistic study. Bipolar Disord 2002: 4: 307–314. © Blackwell Munksgaard 2002Objective: To assess the antidepressant efficacy and tolerability of adjunctive pramipexole, a D 2 –D 3 dopamine agonist, in patients with drug‐resistant depression.Methods: The study sample consisted of in‐patients with major depressive episode, according to the DSM‐IV, and drug resistance. Pramipexole was added to antidepressant treatment with TCA or SSRI, at increasing doses from 0.375 to 1.0 mg/day. Two independent response criteria were adopted: a >50% reduction of the Montgomery–Asberg Depressive Rating Scale (MADRS) total score and a score of 1 or 2 on the Clinical Global Impression scale (CGI‐I) at endpoint. Side‐effects were assessed by the Dosage Record Treatment Emergent Symptom Scale (DOTES).Results: Thirty‐seven patients were enrolled. Of these, 16 had unipolar depression and 21 had bipolar depression. Six patients dropped out in the first week. Of the 31 patients included in the analyses, 19 completed the 16‐week follow‐up. Mean maximal dose of pramipexole was 0.95 mg/day. Mean scores on MADRS decreased from 33.3 ± 8.4 at baseline to 13.9 ± 11.5 at endpoint (p < 0.001) and the CGI‐S decreased from 4.6 ± 0.8 at baseline to 2.8 ± 1.3 at endpoint (p < 0.001). At endpoint, 67.7% (21/31) of patients were responders on MADRS and 74.2% on CGI‐I. Of the 37 patients enrolled, 10 discontinued pramipexole because of adverse events.Conclusions: These preliminary data suggest that pramipexole adjunction to antidepressant treatment may be effective and well tolerated in patients with resistant major depression.