Phase 2
N=9
Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
Fragile X Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01254045 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Eye Contact/Gaze During 10 Minute Social Challenge Task — 15.4; 20.9; 17.0 eye contact/gaze events per 10 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- placebo (Drug); oxytocin 24IU (Drug); oxytocin 48IU (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- Male
- Sponsor
- Stanford University
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eye Contact/Gaze During 10 Minute Social Challenge Task |
15.4; 20.9; 17.0 | — |
| SECONDARY Salivary Cortisol |
6.33; 4.67; 4.37 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Confirmed genetic diagnosis of Fragile X (FraX) (full mutation).
- Male (who have more serious effects due to the X chromosome nature of the disorder)
- Age 13-29 years.
- Parent of adolescent must be willing to sign informed consent.
- Intelligence Quotient (IQ) > 42.
Exclusion Criteria
- Cardiac risk factors.
- Medication exclusions: opiates or opiate antagonists, corticosteroids, typical or atypical antipsychotics.
Data sourced from ClinicalTrials.gov (NCT01254045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.