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Antipsychotic Effects of Oxytocin

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Oxytocin
Placebo
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring oxytocin

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult men or women, 21 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 an atypical antipsychotic medication (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 screening and 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 DSM-IV diagnosis other than Schizophrenia.

Permitted:

  • Subjects on one SSRI, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study. Minor adjustments in sleep medication are acceptable. Patients will be asked to notify the study doctor of any changes to sleep aids.

Sites / Locations

  • University of California, Irvine
  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Oxytocin: Low Dose

Oxytocin: High Dose

Placebo

Arm Description

42 IU BID for the six weeks

84 IU BID for six weeks

Outcomes

Primary Outcome Measures

Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint
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 of Illness (CGI-S)
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 DualDisplayTM System (CMINDS®)
The CMINDS ® consists of "construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™).
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
The MSCEIT™ ME is a multiple choice test that asses how individuals manage their emotions.
Calgary Depression Scale for Schizophrenia (CDSS)
The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient.
Hamilton-Anxiety Scale (HAM-A)
The HAM-A is a clinician administered scale for the evaluation of anxiety symptoms. It consists of 14 items of which each item is scored 0 (not present) to 4 (very severe).
Paranoid Thoughts Scale (PTS)
The PTS is a self-rated scale to assess current paranoia symptoms. The PTS consists of 32 items that the subject rates from 1 (not at all) to 5 (totally).
Treatment Satisfaction Questionnaire for Medication (TSQM)
The TSMQ is a brief questionnaire asking patients about how satisfied they were with the ease, timing, etc. of the study medication giving a good indication of adherence
Childhood Trauma Questionnaire (CTQ)
The CTQ is a validated measure of adverse early experiences characterized on a measure of Anxiety Sensitivity Index and retrospective childhood maltreatment. A 5-point frequency of occurrence scale is utilized: (1) never true, (2) rarely true, (3) sometimes true, (4) often true, and (5) very often true. Each sub-scale score ranges from 5 (no history of abuse or neglect) to 25 (very extreme history of abuse and neglect).
Experience Close Relationships (ECR)
The ECR is a self-rated questionnaire designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure vs. secure about the extent to which their partner's availability and responsiveness) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others vs. secure depending on others) .
Arizona Sexual Experience Scale (ASEX)
The ASEX is a self-rated scale to assess sexual functioning. The ASEX consists of 5 items that the subject will rate from 1 ("extremely strong", "easily", or "satisfying") to 6 ("absent" or "never") based on how he/she feels at the time.
Social Phobia Inventory (SPIN)
The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations.
Penn Emotion Recognition Test (ER-40)
The ER-40 is a computerized emotion discrimination test presenting 40 color photographs of evoked happy, sad, anger, fear and neutral expressions balanced for poser gender and ethnicity.

Full Information

First Posted
June 3, 2012
Last Updated
November 15, 2019
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01621737
Brief Title
Antipsychotic Effects of Oxytocin
Official Title
Antipsychotic Effects of Oxytocin
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Break in funding
Study Start Date
June 2011 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms despite being on adequate treatment with antipsychotic medication.
Detailed Description
This is two-site clinical study taking place at UCSD and UCI. Approximately 71 patients at each site will be randomly assigned to either intranasal oxytocin or vehicle placebo at this site. The total duration for each individual subject will be 6 weeks on study medication (placebo or 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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin: Low Dose
Arm Type
Experimental
Arm Description
42 IU BID for the six weeks
Arm Title
Oxytocin: High Dose
Arm Type
Experimental
Arm Description
84 IU BID for six weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
42 IU BID for six weeks
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
84 IU BID for six weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle placebo
Primary Outcome Measure Information:
Title
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint
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
6 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
6 weeks
Title
Clinical Global Impression-Severity of Illness (CGI-S)
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
6 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
6 weeks
Title
Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®)
Description
The CMINDS ® consists of "construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™).
Time Frame
6 weeks
Title
Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)
Description
The MSCEIT™ ME is a multiple choice test that asses how individuals manage their emotions.
Time Frame
6 weeks
Title
Calgary Depression Scale for Schizophrenia (CDSS)
Description
The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient.
Time Frame
6 weeks
Title
Hamilton-Anxiety Scale (HAM-A)
Description
The HAM-A is a clinician administered scale for the evaluation of anxiety symptoms. It consists of 14 items of which each item is scored 0 (not present) to 4 (very severe).
Time Frame
6 weeks
Title
Paranoid Thoughts Scale (PTS)
Description
The PTS is a self-rated scale to assess current paranoia symptoms. The PTS consists of 32 items that the subject rates from 1 (not at all) to 5 (totally).
Time Frame
6 weeks
Title
Treatment Satisfaction Questionnaire for Medication (TSQM)
Description
The TSMQ is a brief questionnaire asking patients about how satisfied they were with the ease, timing, etc. of the study medication giving a good indication of adherence
Time Frame
6 weeks
Title
Childhood Trauma Questionnaire (CTQ)
Description
The CTQ is a validated measure of adverse early experiences characterized on a measure of Anxiety Sensitivity Index and retrospective childhood maltreatment. A 5-point frequency of occurrence scale is utilized: (1) never true, (2) rarely true, (3) sometimes true, (4) often true, and (5) very often true. Each sub-scale score ranges from 5 (no history of abuse or neglect) to 25 (very extreme history of abuse and neglect).
Time Frame
6 weeks
Title
Experience Close Relationships (ECR)
Description
The ECR is a self-rated questionnaire designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure vs. secure about the extent to which their partner's availability and responsiveness) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others vs. secure depending on others) .
Time Frame
6 weeks
Title
Arizona Sexual Experience Scale (ASEX)
Description
The ASEX is a self-rated scale to assess sexual functioning. The ASEX consists of 5 items that the subject will rate from 1 ("extremely strong", "easily", or "satisfying") to 6 ("absent" or "never") based on how he/she feels at the time.
Time Frame
6 weeks
Title
Social Phobia Inventory (SPIN)
Description
The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations.
Time Frame
6 weeks
Title
Penn Emotion Recognition Test (ER-40)
Description
The ER-40 is a computerized emotion discrimination test presenting 40 color photographs of evoked happy, sad, anger, fear and neutral expressions balanced for poser gender and ethnicity.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult men or women, 21 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 an atypical antipsychotic medication (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 screening and 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 DSM-IV diagnosis other than Schizophrenia. Permitted: Subjects on one SSRI, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study. Minor adjustments in sleep medication are acceptable. Patients will be asked to notify the study doctor of any changes to sleep aids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Feifel, MD, Ph.D
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Potkin, MD
Organizational Affiliation
UCI
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

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Antipsychotic Effects of Oxytocin

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