Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT01254045Other idSU-11182010-7215Other id8618

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 10 participants (actual)
Sponsor: Stanford University · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Feb 2007
Primary completion: Nov 2009
Completion: Jan 2010
First posted: 6 Dec 2010 (estimated)
Last update posted: 18 Mar 2020
Conditions: Fragile X Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20072008200920102011

Ph 2
Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
NCT01254045
Feb 2007 to Jan 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

placeboDrug
oxytocin 24IUDrug
oxytocin 48IUDrug

Arms6

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
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
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
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
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
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Eye Contact/Gaze During 10 Minute Social Challenge Task
Time frame · baseline, week 2, and week 3
Registry description
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.

Secondary outcomes(1)

Salivary Cortisol
Time frame · baseline, week 2, and week 3
Registry description
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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline, week 2, and week 3

Eye Contact/Gaze During 10 Minute Social Challenge Task

Group	Value (eye contact/gaze events per 10 minutes)	Spread
Placebo	15.4	3.5
Oxytocin 24IU/Placebo 24IU	20.9	3.6
48IU OT	17.0	4.5

Secondary and other outcome results(1)

Secondary outcomeMean· baseline, week 2, and week 3

Salivary Cortisol

Group	Value (nmol/L)	Spread
Placebo	6.33	.86
24IU OT	4.67	.56
48IU OT	4.37	.92

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Intervention: Placebo 48IUTwo participants received placebo 48IU at baseline. Three participants received placebo 48IU at Time 2. Three participants received placebo 48IU at Time 3. This study is a cross-over design.	–	0 / 8	0 / 8
Intervention: Oxytocin 24IU/Placebo 24IUThree participants received Oxytocin 24IU/Placebo 24IU at baseline. Three participants received Oxytocin 24IU/Placebo 24IU at Time 2. Two participants received Oxytocin 24IU/Placebo 24IU at Time 3. This study is a cross-over design.	–	0 / 8	1 / 8
Intervention: Oxytocin 48IUThree participants received Oxytocin 48IU at baseline. Two participants received Oxytocin 48IU at Time 2. Three participants received Oxytocin 48IU at Time 3. This study is a cross-over design.	–	0 / 8	0 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

5 results

Effects of intranasal oxytocin on social anxiety in males with fragile X syndrome.

Hall et al. 2012Psychoneuroendocrinologycited by 107

PMID 21862226PMC3353652DOI 10.1016/j.psyneuen.2011.07.020PUB-21862226

Rights unknown5 results

Source link See results (5)

Eligibility

Who could join, as posted.

Sex: Male
Age: from 13 Years up to 29 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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