Antipsychotic Effects of Oxytocin

NCT01621737 | Terminated Results

• 2 other identifiers: 111017R34MH091285
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Keywords

oxytocin

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (14)

• Global Assessment of Functioning (GAF)

  6 weeks

• Clinical Global Impression-Severity of Illness (CGI-S)

  6 weeks

• Clinical Global Impression-Global Improvement (CGI-I)

  6 weeks

• Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®)

  6 weeks

• Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)

  6 weeks

Study Arms (3)

Oxytocin: Low Dose

EXPERIMENTAL

42 IU BID for the six weeks

Drug: Oxytocin

Oxytocin: High Dose

EXPERIMENTAL

84 IU BID for six weeks

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxytocin DRUG

42 IU BID for six weeks

Oxytocin: Low Dose

Placebo DRUG

Vehicle placebo

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of California, Irvine

Irvine, California, 92037, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.

Results Point of Contact

• Title: David Feifel
• Organization: UCSD

dfeifel@kadimanp.com

(858) 412-4130

Study Officials

• David Feifel, MD, Ph.D

  UCSD

  PRINCIPAL INVESTIGATOR

• Steven Potkin, MD

  UCI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Neurosciences Program Director, Neuropsychiatry and Behavioral Medicine Program Director, UCSD Adult ADHD Program

Study Record Dates

• First Submitted: June 3, 2012
• First Posted: June 18, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 19, 2019
• Results First Posted: November 19, 2019

Record last verified: 2019-11

Locations

US (2)