NCT00420459

A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome

Aripiprazole in Fragile X Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 5 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with Fragile X Syndrome.

Detailed description

This 12-week prospective, open-label study design was chosen to gather pilot data for potential future lager scale, double-blind, placebo-controlled studies in Fragile X Syndrome. We hypothesize that aripiprazole will be effective in decreasing aggression, SIB, agitation, and interfering repetitive behavior commonly observed in individuals with Fragile X Syndrome. We also hypothesize that aripiprazole will be well tolerated.

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	Aripiprazole	All subjects will initially receive 2.5 mg/day of aripiprazole during the first week. The dosage may be increased to a maximum of 20 mg/day over 8 weeks.

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-01-11
• Last updated: 2017-04-18
• Results posted: 2017-04-18

Locations

1 site across 1 country: United States