Summary

for people ages 18 years and up (full criteria)
at San Diego, California
study started
estimated completion:
David Feifel

Description

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.

Official Title

Open-label Study of the Long-Term Efficacy of Intranasal Oxytocin in Patients With Schizophrenia

Details

Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.

Keywords

Schizophrenia Oxytocin Oxytocin: 24IU - 168 IU Oxytocin: 24 IU - 168 IU

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Adult men or women, 18 years of age or older.
  2. Meet DSM-IV criteria for Schizophrenia
  3. 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.
  4. 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.
  5. 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.
  6. Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4(moderately ill) at baseline;
  7. Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
  8. Must be able to use nasal spray
  9. Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.

You CAN'T join if...

  1. Are pregnant or are breastfeeding (negative pregnancy test at screening)
  2. A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse
  3. Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
  4. Are unsuitable in any way to participate in this study, in the opinion of the investigator.
  5. Another current, primary DSM-IV diagnosis other than Schizophrenia

Location

  • UCSD Medical Center - Hillcrest
    San Diego California 92103 United States

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02144155
Lead Scientist
David Feifel
Study Type
Interventional
Last Updated
January 2017