NCT00086645

Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1)

Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism.

Detailed description

For children with autism spectrum disorders (ASD, also known as Pervasive Developmental Disorders - PDDs), repetitive behaviors are common and frequently interfere with functioning in the home as well as in social and educational settings. These behaviors may involve repetitive movements, rigid routines, repetitive play, and even repetitive speech. These behaviors may be associated with high levels of anxiety, severe tantrums. Self-injury can occur when these behaviors and routines are interrupted. Participants will be randomly assigned to receive citalopram or placebo (administered as liquid), and carefully followed every two weeks. At the end of 12 weeks, children who have responded to treatment will be given the opportunity to continue in the study, with monthly visits, for an additional 24 weeks. Children who received placebo and did not respond to treatment at 12 weeks will be given the opportunity to receive a carefully monitored 12 week course of citalopram.

Conditions

• Autistic Disorder

Interventions

Type	Name	Description
DRUG	citalopram hydrobromide	10mg/5ml solution
OTHER	placebo	up to equivalent of 20 mg of active comparator daily

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-10-01
• Completion: 2007-04-01
• First posted: 2004-07-13
• Last updated: 2017-03-10

Locations

6 sites across 1 country: United States