A multicenter investigation of fixed-dose fluoxetine in the treatment of obsessive-compulsive disorder.
OBJECTIVE
To determine the effectiveness of fluoxetine hydrochloride at fixed doses of 20 mg/d, 40 mg/d, and 60 mg/d in patients with obsessive-compulsive disorder (OCD) and to evaluate its safety.


METHODS
Fixed-dose fluoxetine hydrochloride (20 mg/d, 40 mg/d, 60 mg/d) was compared with placebo in two randomized, double-blind, parallel, 13-week trials of identical design in 355 outpatients with OCD aged 15 to 70 years (DSM-III-R criteria; 1 year's duration or longer; depression secondary if present).


RESULTS
Fluoxetine (all doses) was significantly (P < or = .001) superior to placebo on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score (mean baseline-to-end-point decrease, 4.6, 5.5, and 6.5 vs 0.9, respectively, studies pooled) and other efficacy measures (P < or = .01). A trend suggesting greater efficacy at 60 mg/d was observed. Most patients (79.2%) completed the study. Eight adverse events were statistically significantly more frequent with fluoxetine and one, with placebo. For some events, incidence tended to increase with increasing dosage; however, few patients discontinued treatment for any single event.


CONCLUSIONS
Fluoxetine was associated with a statistically significant reduction in OCD severity, including time engaged in obsessional and/or compulsive behaviors. Adverse events infrequently led to study discontinuation.
Tollefson
G D
GD
Psychopharmacology Division, Eli Lilly and Company, Indianapolis, Ind.
Rampey
A H
AH
Potvin
J H
JH
Jenike
M A
MA
Rush
A J
AJ
kominguez
R A
RA
Koran
L M
LM
Shear
M K
MK
Goodman
W
W
Genduso
L A
LA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009771:Obsessive-Compulsive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index
D010919:Placebos; D005473:Fluoxetine