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

NCT01254045 | Completed Phase 2 Results

• 2 other identifiers: SU-11182010-72158618
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 behaviors and reducing social anxiety.

Conditions

Fragile X Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Salivary Cortisol

  baseline, week 2, and week 3

Study Arms (6)

placebo, oxytocin 24IU, oxytocin 48IU

EXPERIMENTAL

intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles

Drug: placebo; Drug: oxytocin 24IU; Drug: oxytocin 48IU

oxytocin 24IU, placebo, oxytocin 48IU

EXPERIMENTAL

intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles

Drug: placebo; Drug: oxytocin 24IU; Drug: oxytocin 48IU

oxytocin 48IU, oxytocin 24IU, placebo

EXPERIMENTAL

intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles

Drug: placebo; Drug: oxytocin 24IU; Drug: oxytocin 48IU

oxytocin 24IU, oxytocin 48IU, placebo

EXPERIMENTAL

intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles

Drug: placebo; Drug: oxytocin 24IU; Drug: oxytocin 48IU

oxytocin 48IU, placebo, oxytocin 24IU

EXPERIMENTAL

intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles ; intranasal oxytocin (24 international units) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles

Drug: placebo; Drug: oxytocin 24IU; Drug: oxytocin 48IU

placebo, oxytocin 48IU, oxytocin 24IU

EXPERIMENTAL

intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles

Drug: placebo; Drug: oxytocin 24IU; Drug: oxytocin 48IU

Interventions

placebo DRUG

intranasal placebo (48 international units)

oxytocin 24IU, oxytocin 48IU, placebo; oxytocin 24IU, placebo, oxytocin 48IU; oxytocin 48IU, oxytocin 24IU, placebo; oxytocin 48IU, placebo, oxytocin 24IU; placebo, oxytocin 24IU, oxytocin 48IU; placebo, oxytocin 48IU, oxytocin 24IU

oxytocin 24IU DRUG

intranasal oxytocin (24 international units) and intranasal placebo (24 international units)

Also known as: Syntocinon

oxytocin 24IU, oxytocin 48IU, placebo; oxytocin 24IU, placebo, oxytocin 48IU; oxytocin 48IU, oxytocin 24IU, placebo; oxytocin 48IU, placebo, oxytocin 24IU; placebo, oxytocin 24IU, oxytocin 48IU; placebo, oxytocin 48IU, oxytocin 24IU

oxytocin 48IU DRUG

intranasal oxytocin (48 international units)

Also known as: Syntocinon

oxytocin 24IU, oxytocin 48IU, placebo; oxytocin 24IU, placebo, oxytocin 48IU; oxytocin 48IU, oxytocin 24IU, placebo; oxytocin 48IU, placebo, oxytocin 24IU; placebo, oxytocin 24IU, oxytocin 48IU; placebo, oxytocin 48IU, oxytocin 24IU

Eligibility Criteria

• Age: 13 Years - 29 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Cardiac risk factors.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related 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.

  PMID: 21862226 RESULT

MeSH Terms

Conditions

Fragile X Syndrome

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Scott S. Hall, PhD
• Organization: Stanford University School of Medicine

hallss@stanford.edu

650-498-4799

Study Officials

• Allan L Reiss

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 6, 2010
• Study Start: February 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 18, 2020
• Results First Posted: August 29, 2014

Record last verified: 2020-03

Locations

US (1)