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Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01614093
First Posted: June 7, 2012
Last Update Posted: October 23, 2017
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):
MPRC, University of Maryland
Results First Submitted: April 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
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
17 participants were randomized, 16 participants participated in the trial. All data is available for only 16 participants

Reporting Groups
  Description
Oxytocin/ Placebo Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.

Participant Flow:   Overall Study
    Oxytocin/ Placebo
STARTED   17 
COMPLETED   16 
NOT COMPLETED   1 
Withdrawal by Subject                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.
No text entered.

Reporting Groups
  Description
Oxytocin vs Placebo Participants rated themselves as significantly less hungry when administered OT (M=36.37, SD=21.0) than placebo (M=44.81, SD=28.6) at 60 min. post-preload, F(5, 15)=8.05, p=0.012.

Baseline Measures
   Oxytocin vs Placebo 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Mean (Full Range)
 32 
 (18 to 64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  50.0% 
Male      8  50.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      7  43.8% 
White      7  43.8% 
More than one race      2  12.5% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   16 


  Outcome Measures

1.  Primary:   Food Consumption After Intervention   [ Time Frame: 90 minutes ]


  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
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  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: Kimberly R. Warren, Ph.D.
Organization: Morgan State University
phone: 443-885-3492
e-mail: kimberly.warren@gmail.com



Responsible Party: MPRC, University of Maryland
ClinicalTrials.gov Identifier: NCT01614093     History of Changes
Other Study ID Numbers: HP-00049602
First Submitted: March 20, 2012
First Posted: June 7, 2012
Results First Submitted: April 14, 2017
Results First Posted: September 21, 2017
Last Update Posted: October 23, 2017