ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01254045
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fragile X Syndrome
Interventions Drug: placebo
Drug: oxytocin 24IU
Drug: oxytocin 48IU
Enrollment 10
Recruitment Details  
Pre-assignment Details Ten enrolled. One on antipsychotic mediation at baseline excluded, and one lost to follow-up after baseline. Eight participants included in data analysis. Each participant received a dose of either oxytocin(OT) 24 international units (IU)/intranasal placebo 24IU, OT 48IU, or placebo 48IU at each of 3 weekly visits.
Arm/Group Title Placebo 48IU, Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU Oxytocin 24IU/Placebo 24IU, Placebo 48IU, Oxytocin 48IU Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU, Placebo 48IU Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU, Placebo 48IU Oxytocin 48IU, Placebo 48IU, Oxytocin 24IU/Placebo 24IU Placebo 48IU, Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU
Hide Arm/Group Description 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 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 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 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 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 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; 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 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
Period Title: First/Baseline (1 Day at Week 1 )
Started 2 [1] 2 2 1 1 1
Completed 1 2 2 1 1 1
Not Completed 1 0 0 0 0 0
Reason Not Completed
Lost to Follow-up             1             0             0             0             0             0
[1]
One completed all baseline measures including administration of placebo, but then lost to follow-up.
Period Title: Second/Time 2 (1 Day at Week 2)
Started 1 2 2 1 1 1
Completed 1 2 2 1 1 1
Not Completed 0 0 0 0 0 0
Period Title: Third/Time 3 (1 Day at Week 3)
Started 1 2 2 1 1 1
Completed 1 2 2 1 1 1
Not Completed 0 0 0 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Includes groups randomized to one of six different sequences of three interventions (placebo, oxytocin 24IU, oxytocin 48IU).
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
Ten enrolled. One not randomized because on antipsychotic mediation at baseline. Nine started and one lost to follow-up after baseline. Eight participants were included in data analysis. Each participant received a dose of either 24IU oxytocin, 48IU oxytocin or placebo at each of 3 visits, spaced 1 wk apart, to the lab (i.e., baseline, wk 2, wk 3).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
2
  22.2%
Between 18 and 65 years
7
  77.8%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
20.89  (4.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
0
   0.0%
Male
9
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Eye Contact/Gaze During 10 Minute Social Challenge Task
Hide 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.
Time Frame baseline, week 2, and week 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Oxytocin 24IU/Placebo 24IU 48IU OT
Hide Arm/Group Description:
placebo (48IU)
24 international units of intranasal oxytocin and 24 international units of placebo
48 international units of intranasal oxytocin
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Error)
Unit of Measure: eye contact/gaze events per 10 minutes
15.4  (3.5) 20.9  (3.6) 17.0  (4.5)
2.Secondary Outcome
Title Salivary Cortisol
Hide 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)
Time Frame baseline, week 2, and week 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo 24IU OT 48IU OT
Hide Arm/Group Description:
placebo (48 IU)
24 international units of intranasal oxytocin and 24 IU of placebo
48 international units of intranasal oxytocin
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Error)
Unit of Measure: nmol/L
6.33  (.86) 4.67  (.56) 4.37  (.92)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention: Placebo 48IU Intervention: Oxytocin 24IU/Placebo 24IU Intervention: Oxytocin 48IU
Hide Arm/Group Description Two 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. Three 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. Three 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.
All-Cause Mortality
Intervention: Placebo 48IU Intervention: Oxytocin 24IU/Placebo 24IU Intervention: Oxytocin 48IU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention: Placebo 48IU Intervention: Oxytocin 24IU/Placebo 24IU Intervention: Oxytocin 48IU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention: Placebo 48IU Intervention: Oxytocin 24IU/Placebo 24IU Intervention: Oxytocin 48IU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      1/8 (12.50%)      0/8 (0.00%)    
Nervous system disorders       
Bell's palsy *  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Scott S. Hall, PhD
Organization: Stanford University School of Medicine
Phone: 650-498-4799
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 Submitted: December 2, 2010
First Posted: December 6, 2010
Results First Submitted: August 3, 2011
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014