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

Fragile X Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254045
• Other study ID #: SU-11182010-7215
• Secondary ID: 8618
• Status: Completed
• Phase: Phase 2
• Start date: February 2007
• Est. completion date: January 2010

Study information

• Verified date: March 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 29 Years

Eligibility

Inclusion Criteria:

1. Confirmed genetic diagnosis of Fragile X (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. Intelligence Quotient (IQ) > 42.

Exclusion Criteria:

1. Cardiac risk factors.

2. Medication exclusions: opiates or opiate antagonists, corticosteroids, typical or atypical antipsychotics.

Related Conditions & MeSH terms

• Fragile X Syndrome
• Syndrome

Intervention

Drug:
• placebo
intranasal placebo (48 international units)
• oxytocin 24IU
intranasal oxytocin (24 international units) and intranasal placebo (24 international units)
• oxytocin 48IU
intranasal oxytocin (48 international units)

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hall SS, Lightbody AA, McCarthy BE, Parker KJ, Reiss AL. Effects of intranasal oxytocin on social anxiety in males with fragile X syndrome. Psychoneuroendocrinology. 2012 Apr;37(4):509-18. doi: 10.1016/j.psyneuen.2011.07.020. Epub 2011 Aug 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eye Contact/Gaze During 10 Minute Social Challenge Task	Number of times that eye gaze occurred (i.e., participant looked at female experimenter in the eyes) during 10 minute social challenge task (first 5 minutes social proximity, second 5 minutes social interaction). The social challenge task occurred 50 minutes after internasal dose (of placebo, placebo + oxytocin, or oxytocin) at baseline, week 2, and week 3 visits.	baseline, week 2, and week 3
Secondary	Salivary Cortisol	salivary cortisol level measured immediately before social challenge task and 20 minutes following social challenge task at each time point (i.e., baseline, week 2, and week 3)	baseline, week 2, and week 3