Summary

for males ages 18-45 (full criteria)
healthy people welcome
at UCSF
study started
estimated completion:
Josh D Woolley (ucsf)

Description

Summary

In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia and other psychotic disorders. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders. Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia. Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo. Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.

Official Title

Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral

Details

Part 2: A supplementary study will be added to the proposed parent study, which includes additional behavioral testing consisting of several social cognition computer tasks, clinical assessments, physiological measurements, and questionnaires. The study will be conducted with the same study arms and study interventions as in the proposed parent study. For this supplementary study, the inclusion criteria has broadened to include patients with bipolar disorder with psychotic features and brief psychotic disorder.

Keywords

Schizophrenia Oxytocin Social Cognition Psychotic Disorders Syntocinon Psychosis Schizoaffective Disorder Schizophreniform Disorder Mental Disorders Saline Nasal Spray

Eligibility

You can join if…

Open to males ages 18-45

for Patients:

  • 18 to 45 years of age
  • Clinically stable
  • English Speaking
  • Meet DSM-5 criteria for schizophrenia, schizophreniform, schizoaffective disorder,bipolar disorder with psychotic features, or brief psychotic disorder
  • No or at most only minor changes to medications in the past week
  • Able to use nasal spray
  • Must be capable of providing informed consent

Inclusion Criteria for healthy volunteers:

  • 18 to 45 years of age
  • Clinically stable
  • English Speaking
  • No diagnosis of mental disorder according to DSM-5, not including mild alcohol use disorder or mild cannabis use disorder
  • Able to use nasal spray
  • Must be capable of providing informed consent

You CAN'T join if...

for Patients:

  • Active substance and alcohol use disorder in the past month as determined by the DSM-5 criteria, not including cannabis use disorder
  • Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
  • Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
  • Hearing deficits
  • Pregnancy
  • Severe brain trauma

Exclusion Criteria for Healthy Controls:

  • Active substance and moderate/severe alcohol use disorder, or mood disorder in the past month as determined by the DSM-5 criteria, not including mild alcohol use disorder or mild cannabis use disorder
  • Meet for a current psychiatric disorder according to DSM-5 criteria
  • Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
  • Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
  • Hearing deficits
  • Pregnancy
  • Severe brain trauma

Locations

  • San Francisco Veterans Affairs Medical Center accepting new patients
    San Francisco California 94121 United States
  • University of California, San Francisco in progress, not accepting new patients
    San Francisco California 94143 United States

Lead Scientist

  • Josh D Woolley (ucsf)
    Dr. Woolley has been studying the underpinnings of social deficits in schizophrenia and has examined how oxytocin might be a useful treatment for these social deficits. People with schizophrenia often have functionally significant social cognitive deficits, and there are currently no available pharmacological treatments that target these deficits.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02567032
Phase
Phase 1
Study Type
Interventional
Last Updated