International Meeting for Autism Research (London, May 15-17, 2008): Fluoxetine vs. Placebo for Repetitive Behaviors and Global Functioning in Adults with ASDs

Friday, May 16, 2008

Champagne Terrace/Bordeaux (Novotel London West)

L. Soorya , Psychiatry, Mount Sinai School of Medicine, New York, NY

W. Chaplin , Psychology, St John's University, Jamaica, NY

E. Anagnostou , Psychiatry, Mount Sinai School of Medicine, New York, NY

C. Settipani , Psychiatry, Mount Sinai School of Medicine, New York, NY

E. Hollander , Psychiatry, Mount Sinai School of Medicine, New York, NY

Background: Serotonin reuptake inhibitors are among the most widely utilized psychopharmacological treatments for individuals with ASD, with use increasing 3.5 times in the eight-year period between 1993-2001 (Aman, et al., 2005). The present study represents the first large-scale, double-blind, placebo controlled trial of fluoxetine in adults with autism.

Objectives: The primary objective of this study was to evaluate the effects of fluoxetine on repetitive behaviors in adults with ASDs

Methods: This study utilized a 12-week, randomized, double-blind, parallel-group, placebo-controlled study design. Study medications were dispensed in an identical, double-blind fashion with dosage following a fixed schedule in the first two weeks and thereafter if tolerated participants. Blinded study psychiatrists completed ratings on the outcome measures including the Y-BOCS and CGI during bi-weekly clinic visits.

Results: Forty-eight adults ages 18-65, with a DSM-IV diagnosis of an ASD, confirmed by ADOS and/or ADI, were screened for the study; with 36 participants randomized and included in the analysis. Analysis of dosing patterns suggest the mean endpoint and peak dose for the sample was 64.76 mg (sd=29.09), occurring at week 8. Mixed regression models with observations nested within subjects were used to analyze Y-BOCS Compulsion subscale data. Treatment by linear interaction indicates a significant reduction in compulsion scores of the Y-BOCS across time for the fluoxetine treatment group compared to placebo (z= -2.432, p-.015, d=.527), with endpoint differences yielding a moderate effect size. Independent sample t-tests of the CGI-Improvement-Obsessive Compulsive (CGI-I-OC) scores and CGI-Improvement-Global (CGI-I-G) at week 12 also suggest significant improvements both CGI-I-OC and CGI-I-G ratings for the treatment group.

Conclusions: The results of this clinical trial suggest fluoxetine is more effective than placebo in the treatment of repetitive behaviors and global functioning in adults with ASDs; and appeared to be well-tolerated with only mild and moderate side effects in the treatment group

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