Antipsychotic Effects of Oxytocin

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of California, San Diego
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Feifel, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01621737
First received: June 3, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention
Schizophrenia
Drug: Oxytocin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Antipsychotic Effects of Oxytocin

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Change in Total score in the Positive and Negative Syndrome Scale (PANSS)from baseline to endpoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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®) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The MSCEIT™ ME is a multiple choice test that asses how individuals manage their emotions.

  • Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 143
Study Start Date: June 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621737

Contacts
Contact: Nicholas L Schaffner, B.A. 619-543-5978 nschaffner@ucsd.edu
Contact: Rebecca A McKinney, B.A. 619-471-0313 rmckinney@ucsd.edu

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92037
Contact: Ioana Popica    714-456-8517    ipopica@uci.edu   
Principal Investigator: Steven Potkin, MD         
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Nicholas L Schaffner, B.A.    619-543-5978    nschaffner@ucsd.edu   
Contact: Rebecca A McKinney, B.A.    (619) 471-0313    rmckinney@ucsd.edu   
Principal Investigator: David Feifel, MD, PhD         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: David Feifel, MD, Ph.D UCSD
Principal Investigator: Steven Potkin, MD UCI
  More Information

No publications provided

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
ClinicalTrials.gov Identifier: NCT01621737     History of Changes
Other Study ID Numbers: 111017, R34MH091285
Study First Received: June 3, 2012
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
oxytocin

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Oxytocin
Antipsychotic Agents
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 26, 2014