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

NCT01254045 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-03-18

Study results available
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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.

Conditions

  • Fragile X Syndrome

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Allan L Reiss · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Max Age
29 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-11-30
Completion
2010-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01254045 on ClinicalTrials.gov