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A Study of Oxytocin in Children and Adolescents With Autistic Disorder (Oxytocin)

This study has been completed.
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01308749
First received: February 28, 2011
Last updated: June 15, 2017
Last verified: June 2017
Results First Received: February 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Autism
Interventions: Drug: Oxytocin
Drug: Placebo

  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
This study is a 2 sequence (arm) study with 2 periods - double-blind (0-8 weeks) and open label (8-16 weeks). The sequences are 1: oxytocin-oxytocin and 2: placebo-oxytocin. 1 participant from sequence 1 did not enter period 2 due to withdrawal due to adverse events.

Reporting Groups
  Description
Sequence 1: Oxytocin-oxytocin 8 weeks of double blind oxytocin followed by 8 weeks of open label oxytocin
jSequence 2: Placebo-oxytocin 8 weeks of of double blind placebo followed by 8 weeks of open-label oxytocin; this is the control group

Participant Flow for 2 periods

Period 1:   Period 1: Double Blind Treatment
    Sequence 1: Oxytocin-oxytocin   jSequence 2: Placebo-oxytocin
STARTED   12   13 
COMPLETED   11   13 
NOT COMPLETED   1   0 
Adverse Event                1                0 

Period 2:   Period 2: Open Label Treatment
    Sequence 1: Oxytocin-oxytocin   jSequence 2: Placebo-oxytocin
STARTED   11   13 
COMPLETED   11   11 
NOT COMPLETED   0   2 
Adverse Event                0                1 
Lost to Follow-up                0                1 



  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.
The one participant in the oxytocin group who dropped out after 2 days is not included in the demographics or outcome analyses since no post baseline data other than AEs was obtained. This participant is included in the AE analysis.

Reporting Groups
  Description
Sequence 2:Placebo-oxytocin

Intervention: Drug: placebo

Placebo: Placebo Nasal Spray

Sequence 1: Oxytocin-oxytocin

Intervention: Drug: Syntocinon® Nasal Spray

Oxytocin: Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.

Subjects ages 3-10 years old will be titrated up to a maximum dose of 24 international units (IU). Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU.

Total Total of all reporting groups

Baseline Measures
   Sequence 2:Placebo-oxytocin   Sequence 1: Oxytocin-oxytocin   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   12   25 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      13 100.0%      12 100.0%      25 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 10.0  (4.4)   10.6  (4.4)   10.3  (4.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  15.4%      0   0.0%      2   8.0% 
Male      11  84.6%      12 100.0%      23  92.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      13 100.0%      12 100.0%      25 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   7.7%      0   0.0%      1   4.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   7.7%      2  16.7%      3  12.0% 
White      11  84.6%      10  83.3%      21  84.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Non-verbal 
[Units: Participants]
Count of Participants
 7   4   11 
Intelligence Quotient (IQ) <70 
[Units: Participants]
Count of Participants
 10   4   14 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Could Tolerate Twice Daily Oxytocin   [ Time Frame: Week 0 to week 8 ]

2.  Primary:   Number of Participants Who Could Tolerate Twice Daily Oxytocin   [ Time Frame: Week 0 to week 16 ]

3.  Secondary:   Change in Mean Plasma Oxytocin Level During Period 1 - Double Blind Phase   [ Time Frame: Week 0 to week 8 ]

4.  Secondary:   Change in Mean Weight   [ Time Frame: between weeks 0 and 8 ]

5.  Secondary:   Change in Mean Total Social Social Responsiveness Scale (SRS) T-score   [ Time Frame: 0-8 weeks, blinded treatment, period 1 ]

6.  Secondary:   Change in Mean Autism Diagnostic Observation Schedule (ADOS) Total Score   [ Time Frame: Baseline to 16 Weeks ]

7.  Secondary:   Change in Mean Aberrant Behavior Checklist (ABC)-Social Withdrawal Subscale Score Over Both Periods   [ Time Frame: Baseline to 16 Weeks ]

8.  Secondary:   Change in Mean Pervasive Developmental Disorder Behavior Inventory - Screening Version (PDDBI-SV) Total Score Over Both Periods   [ Time Frame: Baseline to 16 Weeks ]

9.  Secondary:   Change in Mean Systolic Blood Pressure During Period 1   [ Time Frame: Week 0 to 8 ]

10.  Secondary:   Mean Change in Prolactin Levels Over Period 1   [ Time Frame: Week 0 to 8 ]

11.  Secondary:   Mean Change in Temperature During Period 1   [ Time Frame: Week 0 to 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This was a very small study with a very heterogeneous sample. Further the two groups included very different proportions of intellectually disabled non-verbal participants which may influence assessment of benefit.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linmarie Sikich, MD
Organization: Duke University Center for Autism and Brain Development
phone: 9196810026
e-mail: linmarie.sikich@duke.edu



Responsible Party: Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01308749     History of Changes
Other Study ID Numbers: 11-0493
Study First Received: February 28, 2011
Results First Received: February 23, 2017
Last Updated: June 15, 2017