ACTRN12608000173392.
| Trial name or title | Fluoxetine for the treatment of repetitive behaviours in children and adolescents with autism: A randomised double‐blind placebo‐controlled trial. |
| Methods | Parallel randomised controlled trial |
| Participants | Boys and girls aged 8 to 17 years who 1. meet criteria for an ASD based on the DSM‐IV or ICD‐10. 2. have a score of ≥ 15 on the total score of the Repetitive Behavior Scale ‐ Revised (RBS‐R) at the time of screening. Participants with an intellectual disability must have previously documented psychometric testing. |
| Interventions | Fluoxetine or placebo (sugar syrup) will be administered as an oral syrup (2 mg/ml), once daily. Trial medication (fluoxetine or placebo) will begin at 2 mg/day, and increased in weekly increments of 2 mg (provided that side effects do not emerge), until an effective dose is reached. The maximum dose will be 12 mg/day by week 6 of the trial. The final effective dose will be maintained from week 7 to 12 of the trial. Placebo (sugar syrup with raspberry flavouring). The placebo syrup will be of similar appearance and taste to the fluoxetine syrup. The packaging for both will be identical. |
| Outcomes | Primary outcomes: Total score on the RBS‐R. Secondary outcome:Score for each subscale of the RBS‐R. |
| Starting date | 2010 |
| Contact information | |
| Notes | Ongoing. Recruitment slower than anticipated. |