NCT01254045

Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Male
• Age: 13 Years – 29 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the medication oxytocin is an effective and tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving socially appropriate behaviors and reducing social anxiety.

Detailed description

Twelve male adolescent (13-24 years) subjects with confirmed genetic diagnosis of FraX (full mutation) will participate in this randomized double-blind placebo-controlled study. They will receive a dose of either 24 IU oxytocin, 48 IU oxytocin or placebo at each of three visits to the lab, with each visit spaced one week apart. The efficacy of each dose will be evaluated using behavioral, cognitive and physiological metrics. If individual subject results suggest that either of the oxytocin dosage levels (24 IU or 48 IU) is superior to placebo in the double-blind phase, a single-blind trial using the optimal dosage of oxytocin will then be administered daily for 14 days by parents at home. Subjects will then come into the lab for a final assessment on Day 30. Determination of beneficial response to oxytocin will be based on a 20% change (improvement) in behavior or test performance (see below). If both oxytocin dosage levels provide similar benefits compared to placebo, the lower dose will be chosen for the 14 day single-blind trial.

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	placebo	intranasal placebo (48 international units)
DRUG	oxytocin 24IU	intranasal oxytocin (24 international units) and intranasal placebo (24 international units)
DRUG	oxytocin 48IU	intranasal oxytocin (48 international units)

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-11-01
• Completion: 2010-01-01
• First posted: 2010-12-06
• Last updated: 2020-03-18
• Results posted: 2014-08-29

Locations

1 site across 1 country: United States