Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
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ClinicalTrials.gov Identifier: NCT01254045 |
Recruitment Status
:
Completed
First Posted
: December 6, 2010
Results First Posted
: August 29, 2014
Last Update Posted
: August 29, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fragile X Syndrome | Drug: placebo Drug: oxytocin 24IU Drug: oxytocin 48IU | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: placebo, oxytocin 24IU, oxytocin 48IU
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
intranasal placebo (48 international units)
Drug: oxytocin 24IU
intranasal oxytocin (24 international units) and intranasal placebo (24 international units)
Other Name: Syntocinon
Drug: oxytocin 48IU
intranasal oxytocin (48 international units)
Other Name: Syntocinon
|
Experimental: oxytocin 24IU, placebo, oxytocin 48IU
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
intranasal placebo (48 international units)
Drug: oxytocin 24IU
intranasal oxytocin (24 international units) and intranasal placebo (24 international units)
Other Name: Syntocinon
Drug: oxytocin 48IU
intranasal oxytocin (48 international units)
Other Name: Syntocinon
|
Experimental: oxytocin 48IU, oxytocin 24IU, placebo
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
intranasal placebo (48 international units)
Drug: oxytocin 24IU
intranasal oxytocin (24 international units) and intranasal placebo (24 international units)
Other Name: Syntocinon
Drug: oxytocin 48IU
intranasal oxytocin (48 international units)
Other Name: Syntocinon
|
Experimental: oxytocin 24IU, oxytocin 48IU, placebo
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
intranasal placebo (48 international units)
Drug: oxytocin 24IU
intranasal oxytocin (24 international units) and intranasal placebo (24 international units)
Other Name: Syntocinon
Drug: oxytocin 48IU
intranasal oxytocin (48 international units)
Other Name: Syntocinon
|
Experimental: oxytocin 48IU, placebo, oxytocin 24IU
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
intranasal placebo (48 international units)
Drug: oxytocin 24IU
intranasal oxytocin (24 international units) and intranasal placebo (24 international units)
Other Name: Syntocinon
Drug: oxytocin 48IU
intranasal oxytocin (48 international units)
Other Name: Syntocinon
|
Experimental: placebo, oxytocin 48IU, oxytocin 24IU
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
intranasal placebo (48 international units)
Drug: oxytocin 24IU
intranasal oxytocin (24 international units) and intranasal placebo (24 international units)
Other Name: Syntocinon
Drug: oxytocin 48IU
intranasal oxytocin (48 international units)
Other Name: Syntocinon
|
- Eye Contact/Gaze During 10 Minute Social Challenge Task [ Time Frame: baseline, week 2, and week 3 ]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.
- Salivary Cortisol [ Time Frame: baseline, week 2, and week 3 ]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)

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Ages Eligible for Study: | 13 Years to 29 Years (Child, Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- Cardiac risk factors.
- Medication exclusions: opiates or opiate antagonists, corticosteroids, typical or atypical antipsychotics.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254045
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Allan L Reiss | Stanford University |
Publications of Results:
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT01254045 History of Changes |
Other Study ID Numbers: |
SU-11182010-7215 8618 ( Other Identifier: Stanford University IRB eProtocol ) |
First Posted: | December 6, 2010 Key Record Dates |
Results First Posted: | August 29, 2014 |
Last Update Posted: | August 29, 2014 |
Last Verified: | August 2014 |
Additional relevant MeSH terms:
Fragile X Syndrome Syndrome Disease Pathologic Processes 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 |