A non-comparative assessment of tolerability and efficacy of duloxetine in the treatment of depressed patients with Parkinson's disease.
OBJECTIVE
Depression is a comorbidity affecting quality of life (QoL) in patients with Parkinson's disease (PD) and requires appropriate treatment. This study evaluated the tolerability, safety, and efficacy of duloxetine 60 mg once daily for 12 weeks in PD patients with major depressive disorder (MDD).


METHODS
Non-comparative, open-label, multi-center study.


METHODS
Tolerability was evaluated by discontinuation rate (acceptable if ≤ 19%) due to treatment-emergent adverse events (TEAEs) and motor symptoms (UPDRS). Safety measures were TEAEs, the UKU side effect rating scale, vital signs, weight, laboratory tests, and ECG. Efficacy measures included HAMD-17, BDI, CGI-S, PGI-I, and pain VAS. QoL was measured by PDQ-39.


RESULTS
Of the 151 patients enrolled, 8.6% (95% upper CI: 13.3%) discontinued the study due to TEAEs. Worsening in PD-related tremor and rigidity was not observed, activities of daily living significantly improved and UKU subscales progressively decreased. Clinically significant abnormalities in laboratory findings were limited to four cases of hypercholesterolemia and one increase of total bilirubin, CPK, and fasting glucose. Blood pressure, weight, and ECG did not change from baseline. HAMD-17 and PDQ-39 total score and individual domains, BDI, CGI-S, and PGI-I total scores significantly improved.


CONCLUSIONS
Duloxetine seems well tolerated and likely effective in the treatment of depression associated with PD, with no detrimental effects in PD signs and symptoms.
University of Pisa, Department of Neurosciences, Pisa, Italy. u.bonuccelli@med.unipi.it.
Ubaldo
U
Bonuccelli
Giuseppe
G
Meco
Giovanni
G
Fabbrini
Alessandro
A
Tessitore
Mariangela
M
Pierantozzi
Fabrizio
F
Stocchi
Roberto
R
Ceravolo
Carlo
C
Caltagirone
Mauro
M
Silvestrini
Francesca
F
Morgante
Stefano
S
Ruggieri
Laura
L
Avanzino
Michele
M
Guadagna
Grazia
G
Dell'Agnello
Andrea
A
Rossi
Riccardo
R
Spezia
Michele
M
Mancini
D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000150:complications / Q000188:drug therapy*; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy*; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride