Back to resultsOpen-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxytocin: 24IU - 168 IU
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring Oxytocin
Eligibility Criteria
Inclusion Criteria:
- Adult men or women, 18 years of age or older.
- Meet DSM-IV criteria for Schizophrenia
- Women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study.
- Must be on a therapeutic dose of 1 or 2 atypical antipsychotic medications (examples but not limited to Clozapine Olanzapine, Risperidone, Ziprasidone, Aripiprazole, Seroquel) with no major dose changes for at least 4 weeks.
- A minimum PANSS total score of 55 at baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening.
- Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline;
- Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
- Must be able to use nasal spray
- Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
Exclusion Criteria:
- Are pregnant or are breastfeeding (negative pregnancy test at screening)
- A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse
- Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
- Are unsuitable in any way to participate in this study, in the opinion of the investigator.
- Another current, primary DSM-IV diagnosis other than Schizophrenia
Sites / Locations
- UCSD Medical Center - Hillcrest
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Oxytocin: 24 IU - 168 IU
Vehicle placebo
Arm Description
Oxytocin twice daily for 3 weeks
Placebo for 3 weeks
Outcomes
Primary Outcome Measures
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks
The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances.
Secondary Outcome Measures
Global Assessment of Functioning (GAF)
The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning).
Clinical Global Impression-Severity
The CGI-S is used to evaluate changes in overall severity of illness. Scores range from 1 (not at all) to 7 (among the most extremely ill).
Clinical Global Impression-Global Improvement (CGI-I)
The CGI-I is a global assessment to evaluate the subject's improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse).
Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
Full Information
NCT ID
NCT02144155
First Posted
May 19, 2014
Last Updated
December 3, 2019
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT02144155
Brief Title
Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia
Official Title
Open-label Study of the Long-Term Efficacy of Intranasal Oxytocin in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Break in funding
Study Start Date
March 2012 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Objective of this study is to investigate the long-term efficacy of intranasal oxytocin in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute being on adequate treatment with antipsychotic medication.
Detailed Description
Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Oxytocin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin: 24 IU - 168 IU
Arm Type
Experimental
Arm Description
Oxytocin twice daily for 3 weeks
Arm Title
Vehicle placebo
Arm Type
Sham Comparator
Arm Description
Placebo for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Oxytocin: 24IU - 168 IU
Intervention Description
Oxytocin: 24IU - 168 IU
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo drug
Primary Outcome Measure Information:
Title
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks
Description
The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances.
Time Frame
baseline and 28 weeks
Secondary Outcome Measure Information:
Title
Global Assessment of Functioning (GAF)
Description
The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning).
Time Frame
28 weeks
Title
Clinical Global Impression-Severity
Description
The CGI-S is used to evaluate changes in overall severity of illness. Scores range from 1 (not at all) to 7 (among the most extremely ill).
Time Frame
28 Weeks
Title
Clinical Global Impression-Global Improvement (CGI-I)
Description
The CGI-I is a global assessment to evaluate the subject's improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse).
Time Frame
28 Weeks
Title
Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)
Time Frame
28 weeks
Title
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
Time Frame
28 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult men or women, 18 years of age or older.
Meet DSM-IV criteria for Schizophrenia
Women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study.
Must be on a therapeutic dose of 1 or 2 atypical antipsychotic medications (examples but not limited to Clozapine Olanzapine, Risperidone, Ziprasidone, Aripiprazole, Seroquel) with no major dose changes for at least 4 weeks.
A minimum PANSS total score of 55 at baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening.
Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline;
Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
Must be able to use nasal spray
Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
Exclusion Criteria:
Are pregnant or are breastfeeding (negative pregnancy test at screening)
A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse
Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
Are unsuitable in any way to participate in this study, in the opinion of the investigator.
Another current, primary DSM-IV diagnosis other than Schizophrenia
Facility Information:
Facility Name
UCSD Medical Center - Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia
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