Oxytocin Add on Study for Stable Schizophrenic Patients

NCT00506909 | Terminated Results

• 1 other identifier: Oxytocin Schizophrenia
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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)

• Total Score in the Positive and Negative Syndrome Scale (PANSS)

  performed at each visit (weekly)

Secondary Outcomes (12)

• Clinical Global Impression-Severity of Illness

  performed at each visit (weekly)

• Calgary Depression Scale for Schizophrenia

  performed at each visit (weekly)

• Clinical Global Impression-Global Improvement

  Performed at Visits 2-8 (weekly)

• Global Assessment of Functioning

  performed at each visit (weekly)

• Hamilton Anxiety Scale

  performed at each visit (weekly)

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1: 20 IU BID for the first week, 40IU BID for the following two weeks, 1 week washout, 3 week placebo trial.

Drug: Oxytocin; Drug: Placebo

Group 2

EXPERIMENTAL

Group 2: 3 week placebo trial, 1 week washout, 20 IU BID for the first week, 40IU BID for the following two weeks.

Drug: Oxytocin; Drug: Placebo

Interventions

Oxytocin DRUG

20 IU BID or 40 IU BID

Group 1; Group 2

Placebo DRUG

20 IU BID or 40 IU BID

Group 1; Group 2

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 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:

• Subjects will be excluded from the study of they meet any of the following 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.

Sponsors & Collaborators

• David Feifel: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92103, United States

Location

Related Publications (2)

• Feifel D, Macdonald K, Cobb P, Minassian A. Adjunctive intranasal oxytocin improves verbal memory in people with schizophrenia. Schizophr Res. 2012 Aug;139(1-3):207-10. doi: 10.1016/j.schres.2012.05.018. Epub 2012 Jun 8.

  PMID: 22682705 DERIVED

• Feifel D, Macdonald K, Nguyen A, Cobb P, Warlan H, Galangue B, Minassian A, Becker O, Cooper J, Perry W, Lefebvre M, Gonzales J, Hadley A. Adjunctive intranasal oxytocin reduces symptoms in schizophrenia patients. Biol Psychiatry. 2010 Oct 1;68(7):678-80. doi: 10.1016/j.biopsych.2010.04.039. Epub 2010 Jul 7.

  PMID: 20615494 DERIVED

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

Study Officials

• David Feifel, MD, PhD

  University of California, San Diego

  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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: March 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 25, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-06

Locations

US (1)