Status:

COMPLETED

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

Lead Sponsor:

Stanford University

Conditions:

Fragile X Syndrome

Eligibility:

MALE

13-29 years

Phase:

PHASE2

Brief 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 ...

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 do...

Eligibility Criteria

Inclusion

  • 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

  • Cardiac risk factors.
  • Medication exclusions: opiates or opiate antagonists, corticosteroids, typical or atypical antipsychotics.

Key Trial Info

Start Date :

February 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2010

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT01254045

Start Date

February 1 2007

End Date

January 1 2010

Last Update

March 18 2020

Active Locations (1)

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Stanford University School of Medicine

Stanford, California, United States, 94305