Open-label Study of the Efficacy of Intranasal Oxytocin in Schizophrenia

NCT02144155 | Terminated Results

• 1 other identifier: 120005
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Oxytocin

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 28 weeks

Secondary Outcomes (5)

• Global Assessment of Functioning (GAF)

  28 weeks

• Clinical Global Impression-Severity

  28 Weeks

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

  28 Weeks

• Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)

  28 weeks

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

  28 Weeks

Study Arms (2)

Oxytocin: 24 IU - 168 IU

EXPERIMENTAL

Oxytocin twice daily for 3 weeks

Drug: Oxytocin: 24IU - 168 IU

Vehicle placebo

SHAM COMPARATOR

Placebo for 3 weeks

Drug: Oxytocin: 24IU - 168 IU; Drug: Placebo

Interventions

Oxytocin: 24IU - 168 IU DRUG

Oxytocin: 24IU - 168 IU

Oxytocin: 24 IU - 168 IU; Vehicle placebo

Placebo DRUG

placebo drug

Vehicle placebo

Eligibility Criteria

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

You may qualify if:

• 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.

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, primary DSM-IV diagnosis other than Schizophrenia

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center - Hillcrest

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

This study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study. The study data was never analyzed.

Results Point of Contact

• Title: David Feifel
• Organization: UCSD

dfeifel@kadimanp.com

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 9, 2019
• Results First Posted: December 9, 2019

Record last verified: 2019-12

Locations

US (1)