Fluoxetine for the treatment of repetitive behaviours in children and adolescents with autism: A randomised double-blind placebo-controlled trial.

Phase 2

Completed

• Conditions: Repetitve behaviours in autism.; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12608000173392
• Lead Sponsor: Victorian Medical Insurance Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. Subjects (both male and female) will be aged between 7.5 years to 18 years.
2. Subjects will need to meet criteria for an Autism Spectrum Disorder [based on the Diagnostic and statistical Manual of Mental Disorder- 4th Edition (DSM-IV) or the International Classification of Diseases (ICD-10) criteria].
3. Subjects must have a score of 6 or greater on the total score of the Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS) at the time of screening.
4. Subjects must be able to comply with the assessments and procedures required for the trial.
5. Subjects with an intellectual disability must have previously documented psychometric testing.

Exclusion Criteria

1. A DSM-IV diagnosis of Rett’s Disorder, Childhood Disintegrative Disorder, or Schizophrenia.
2. Current use of any psychotropic medication (including typical and atypical anti-psychotics, mood stabilizers, antidepressants, anti-anxiolytics and stimulant medication including atomoxetine, monoamine oxidase inhibitor (MAOI) or pimozide, and St John's wort) or any use of such medication in the 3 months prior to the commencement of the trial.
3. Concomitant administration of drugs that interact with the metabolism of fluoxetine (e.g. phenytoin and carbamazepine).
4. Co-morbid significant medical conditions (e.g. unstable seizure disorder, cardiac disease, liver failure or renal failure).
5. Pregnancy: females of childbearing potential require a urine pregnancy test to exclude pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified