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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01254045
First received: December 2, 2010
Last updated: December 14, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Fragile X Syndrome
Drug: Oxytocin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Eye contact [ Time Frame: 10 mins ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social Responsiveness Scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: February 2007
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxytocin Drug: Oxytocin
oxytocin 24 IU, oxytocin 48 IU, single dose, once
Other Name: oxytocin

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.

  Eligibility

Ages Eligible for Study:   13 Years to 29 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed genetic diagnosis of FraX (full mutation).
  2. Male (who have more serious effects due to the X chromosome nature of the disorder)
  3. Age 13-29 years.
  4. Parent of adolescent must be willing to sign informed consent.
  5. IQ > 42.

Exclusion Criteria:

  1. Cardiac risk factors.
  2. Medication exclusions: opiates or opiate antagonists, corticosteroids, typical or atypical antipsychotics.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01254045

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Allan L Reiss Stanford University
  More Information

No publications provided

Responsible Party: Allan L Reiss, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01254045     History of Changes
Other Study ID Numbers: SU-11182010-7215, 8618
Study First Received: December 2, 2010
Last Updated: December 14, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fragile X Syndrome
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014