Pramipexole in treatment-resistant depression: a 16-week naturalistic study.
OBJECTIVE
To assess the antidepressant efficacy and tolerability of adjunctive pramipexole, a D2-D3 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 I or 2 on the Clinical Global Impression scale (CGI-1) 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.
Lattanzi
Lorenzo
L
Department of Psychiatry, Neurobiology, Pharmacology and Biotechnologies, University of Pisa, Italy. paolo.cassano@psico.med.unipi.it
Dell'Osso
Liliana
L
Cassano
Paolo
P
Pini
Stefano
S
Rucci
Paola
P
Houck
Patricia R
PR
Gemignani
Alfredo
A
Battistini
Giulia
G
Bassi
Annalisa
A
Abelli
Marianna
M
Cassano
Giovanni B
GB
D000328:Adult; D000368:Aged; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use*; D052160:Benzothiazoles; D003131:Combined Modality Therapy; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000628:therapy; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D018432:Drug Resistance, Multiple; D004359:Drug Therapy, Combination; D004565:Electroconvulsive Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077487:Pramipexole; D011446:Prospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D013844:Thiazoles / Q000008:administration & dosage / Q000627:therapeutic use*
D000929:Antidepressive Agents, Tricyclic; D052160:Benzothiazoles; D018491:Dopamine Agonists; D000077487:Pramipexole; D017367:Selective Serotonin Reuptake Inhibitors; D013844:Thiazoles