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-Åsberg 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.


CONCLUSIONS
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.
Inoue
Takeshi
T
Department of Psychiatry, Hokkaido University Graduate School of Medicine, North 15, West 7, Kita-ku, Sapporo 060-8638, Japan. tinoue@med.hokudai.ac.jp
Kitaichi
Yuji
Y
Masui
Takuya
T
Nakagawa
Shin
S
Boku
Shuken
S
Tanaka
Teruaki
T
Suzuki
Katsuji
K
Nakato
Yasuya
Y
Usui
Reiko
R
Koyama
Tsukasa
T
D000328:Adult; D052160:Benzothiazoles / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D000077487:Pramipexole; D011446:Prospective Studies; D016896:Treatment Outcome
D052160:Benzothiazoles; D000077487:Pramipexole