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Oxytocin and CBSST for People With Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01752712
First Posted: December 19, 2012
Last Update Posted: October 31, 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.
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Robert W. Buchanan, University of Maryland
Results First Submitted: October 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: CBSST + Oxytocin
Drug: CBSST + 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CBSST + Oxytocin

Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).

CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.

CBSST + Placebo

Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).

CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.


Participant Flow:   Overall Study
    CBSST + Oxytocin   CBSST + Placebo
STARTED   31   31 
COMPLETED   22   16 
NOT COMPLETED   9   15 



  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.
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Reporting Groups
  Description
CBSST + Oxytocin

Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).

CBSST + Oxytocin: The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.

CBSST + Placebo

Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).

CBSST + Placebo: Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.

Total Total of all reporting groups

Baseline Measures
   CBSST + Oxytocin   CBSST + Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   31   62 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      31 100.0%      31 100.0%      62 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.8  (8.7)   40.7  (10.2)   41.92  (9.46) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  41.9%      11  35.5%      24  38.7% 
Male      18  58.1%      20  64.5%      38  61.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   3.2%      0   0.0%      1   1.6% 
Asian      1   3.2%      3   9.7%      4   6.5% 
Native Hawaiian or Other Pacific Islander      1   3.2%      0   0.0%      1   1.6% 
Black or African American      9  29.0%      7  22.6%      16  25.8% 
White      17  54.8%      15  48.4%      32  51.6% 
More than one race      2   6.5%      6  19.4%      8  12.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   31   31   62 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Birchwood Social Function Scale (BSFS) Total Score   [ Time Frame: Treatment weeks 0, 12, and 24, plus follow-up week 36 ]

2.  Secondary:   Defeatist Performance Attitudes Scale (DPAS) Total Score   [ Time Frame: Treatment weeks 0, 12, and 24, plus follow-up week 36 ]

3.  Secondary:   Asocial Belief Scale (ABS) Total Score   [ Time Frame: Treatment weeks 0, 12, and 24, plus follow-up week 36 ]

4.  Secondary:   Schedule for Assessment of Negative Symptoms (SANS) Total Score   [ Time Frame: Every 4 weeks during the treatment phase, plus follow-up week 36 ]

5.  Secondary:   Brief Psychiatric Rating Scale (BPRS) Total Score   [ Time Frame: Every 4 weeks during the treatment phase, plus follow-up week 36 ]

6.  Secondary:   Brief Psychiatric Rating Scale (BPRS) Psychosis Score   [ Time Frame: Every 4 weeks during the treatment phase, plus follow-up week 36 ]


  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: Robert W. Buchanan, M.D.
Organization: Maryland Psychiatric Research Center
phone: 410-402-7876
e-mail: rwbuchanan@mprc.umaryland.edu



Responsible Party: Robert W. Buchanan, University of Maryland
ClinicalTrials.gov Identifier: NCT01752712     History of Changes
Other Study ID Numbers: HP-00054628
First Submitted: December 14, 2012
First Posted: December 19, 2012
Results First Submitted: October 2, 2017
Results First Posted: October 31, 2017
Last Update Posted: October 31, 2017