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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01254045
First Posted: December 6, 2010
Last Update Posted: September 5, 2014
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.
Information provided by (Responsible Party):
Stanford University
Results First Submitted: August 3, 2011  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo 48IU, Oxytocin 24IU/Placebo 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 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
Oxytocin 24IU/Placebo 24IU, Placebo 48IU, 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
Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU, Placebo 48IU 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
Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU, Placebo 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 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
Oxytocin 48IU, Placebo 48IU, Oxytocin 24IU/Placebo 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; 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
Placebo 48IU, Oxytocin 48IU, Oxytocin 24IU/Placebo 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

Participant Flow for 3 periods

Period 1:   First/Baseline (1 Day at Week 1 )
    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
STARTED   2 [1]   2   2   1   1   1 
COMPLETED   1   2   2   1   1   1 
NOT COMPLETED   1   0   0   0   0   0 
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 2:   Second/Time 2 (1 Day at Week 2)
    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
STARTED   1   2   2   1   1   1 
COMPLETED   1   2   2   1   1   1 
NOT COMPLETED   0   0   0   0   0   0 

Period 3:   Third/Time 3 (1 Day at Week 3)
    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
STARTED   1   2   2   1   1   1 
COMPLETED   1   2   2   1   1   1 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
All Study Participants Includes groups randomized to one of six different sequences of three interventions (placebo, oxytocin 24IU, oxytocin 48IU).

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
 
<=18 years   2 
Between 18 and 65 years   7 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.89  (4.73) 
Gender 
[Units: Participants]
 
Female   0 
Male   9 
Region of Enrollment 
[Units: Participants]
 
United States   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Eye Contact/Gaze During 10 Minute Social Challenge Task   [ Time Frame: baseline, week 2, and week 3 ]

2.  Secondary:   Salivary Cortisol   [ Time Frame: baseline, week 2, and week 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: hallss@stanford.edu


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 Submitted: December 2, 2010
First Posted: December 6, 2010
Results First Submitted: August 3, 2011
Results First Posted: August 29, 2014
Last Update Posted: September 5, 2014