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Antipsychotic Effects of Oxytocin

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. Identifier: NCT01621737
Recruitment Status : Terminated (Break in funding)
First Posted : June 18, 2012
Results First Posted : November 19, 2019
Last Update Posted : November 19, 2019
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Feifel, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Oxytocin Drug: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Antipsychotic Effects of Oxytocin
Actual Study Start Date : June 2011
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin: Low Dose
42 IU BID for the six weeks
Drug: Oxytocin
42 IU BID for six weeks

Experimental: Oxytocin: High Dose
84 IU BID for six weeks
Drug: Oxytocin
84 IU BID for six weeks

Placebo Comparator: Placebo Drug: Placebo
Vehicle placebo

Primary Outcome Measures :
  1. Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint [ Time Frame: 6 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 :
  1. Global Assessment of Functioning (GAF) [ Time Frame: 6 weeks ]
    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).

  2. Clinical Global Impression-Severity of Illness (CGI-S) [ Time Frame: 6 weeks ]
    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).

  3. Clinical Global Impression-Global Improvement (CGI-I) [ Time Frame: 6 weeks ]
    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).

  4. Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®) [ Time Frame: 6 weeks ]
    The CMINDS ® consists of "construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™).

  5. Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME) [ Time Frame: 6 weeks ]
    The MSCEIT™ ME is a multiple choice test that asses how individuals manage their emotions.

  6. Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: 6 weeks ]
    The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient.

  7. Hamilton-Anxiety Scale (HAM-A) [ Time Frame: 6 weeks ]
    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).

  8. Paranoid Thoughts Scale (PTS) [ Time Frame: 6 weeks ]
    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).

  9. Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 6 weeks ]
    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

  10. Childhood Trauma Questionnaire (CTQ) [ Time Frame: 6 weeks ]
    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).

  11. Experience Close Relationships (ECR) [ Time Frame: 6 weeks ]
    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) .

  12. Arizona Sexual Experience Scale (ASEX) [ Time Frame: 6 weeks ]
    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.

  13. Social Phobia Inventory (SPIN) [ Time Frame: 6 weeks ]
    The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations.

  14. Penn Emotion Recognition Test (ER-40) [ Time Frame: 6 weeks ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01621737

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United States, California
University of California, Irvine
Irvine, California, United States, 92037
University of California, San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
National Institute of Mental Health (NIMH)
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Principal Investigator: David Feifel, MD, Ph.D UCSD
Principal Investigator: Steven Potkin, MD UCI
  Study Documents (Full-Text)

Documents provided by David Feifel, University of California, San Diego:

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Responsible Party: David Feifel, Professor of Psychiatry and Neurosciences Program Director, Neuropsychiatry and Behavioral Medicine Program Director, UCSD Adult ADHD Program, University of California, San Diego Identifier: NCT01621737    
Obsolete Identifiers: NCT01987050
Other Study ID Numbers: 111017
R34MH091285 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2012    Key Record Dates
Results First Posted: November 19, 2019
Last Update Posted: November 19, 2019
Last Verified: November 2019
Keywords provided by David Feifel, University of California, San Diego:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs