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Oxytocin and Social Cognition in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT00884897
First received: April 20, 2009
Last updated: May 2, 2017
Last verified: May 2017
Results First Received: February 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Social Cognition
Social Anxiety
Emotional Intelligence
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
No text entered.

Reporting Groups
  Description
Oxytocin

We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.

Oxytocin: Oxytocin given as 20 IU BID

Placebo

We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.

Placebo: Placebo given as 20 IU BID


Participant Flow:   Overall Study
    Oxytocin   Placebo
STARTED   13   15 
COMPLETED   13   15 
NOT COMPLETED   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.
Baseline participants are participants that were randomized to one of the two treatment groups.

Reporting Groups
  Description
Oxytocin

We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.

Oxytocin: Oxytocin given as 20 IU BID

Placebo

We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.

Placebo: Placebo given as 20 IU BID

Total Total of all reporting groups

Baseline Measures
   Oxytocin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   15   28 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.74  (11.74)   35.07  (8.21)   39.6  (11.0) 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      13 100.0%      15 100.0%      28 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  30.8%      4  26.7%      8  28.6% 
Male      9  69.2%      11  73.3%      20  71.4% 
Region of Enrollment 
[Units: Participants]
     
United States   13   15   28 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients   [ Time Frame: participants are assessed at baseline and end point ]

2.  Secondary:   To Determine Whether OT Improves Measures of Social Anxiety.   [ Time Frame: Outcomes are compared between Baseline and endpoint ]


  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
No text entered.


  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: Deanna L. Kelly Pharm.D., BCPP
Organization: Maryland Psychiatric Research Center
phone: 410-402-96860
e-mail: dkelly@mprc.umaryland.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MPRC, University of Maryland
ClinicalTrials.gov Identifier: NCT00884897     History of Changes
Other Study ID Numbers: HP-00041024
P50MH082999 ( U.S. NIH Grant/Contract )
Study First Received: April 20, 2009
Results First Received: February 26, 2015
Last Updated: May 2, 2017