A Double-Blind Placebo-Controlled Trial of Fluoxetine for Repetitive Behaviors and Global Severity in Adult Autism Spectrum Disorders

Objective: The effects of fiuoxetine and placebo on repetitive behaviors and global severity were compared in adults with autism spectrum disorders (ASDs). Method: Adults with ASDs were enrolled in a 12-week double-blind placebo-controlled fiuoxetine trial. Thirty-seven were randomly assigned to fiuoxetine (N=22) or placebo (N=15). Dosage followed a fixed schedule, starting at 10 mg/day and increasing as tolerated up to 80 mg/day. Repetitive behaviors were measured with the compulsion subscale of the Yale-Brown Obsessive Compulsive Scale; the Clinical Global Impression (CGI) improvement scale was used to rate improvement in obsessive-compulsive symptoms and overall severity. Results: There was a significant treatment-by-time interaction indicating a significantly greater reduction in repetitive behaviors across time for fiuoxetine than for placebo. With overall response defined as a CGI global improvement score of 2 or less, there were significantly more responders at week 12 in the fiuoxetine group than in the placebo group. The risk ratio was 1.5 for CGI global improvement (responders: fiuoxetine, 35%; placebo, 0%) and 1.8 for CGI-rated improvement in obsessive-compulsive symptoms (responders: fiuoxetine, 50%; placebo, 8%). Only mild and moderate side effects were observed. Conclusions: Fluoxetine treatment, compared to placebo, resulted in significantly greater improvement in repetitive behaviors, according to both the Yale-Brown compulsion subscale and CGI rating of obsessive-compulsive symptoms, as well as on the CGI overall improvement rating. Fluoxetine appeared to be well tolerated. These findings stand in contrast to findings in a trial of citalopram for childhood autism.