NCT02567032

Adult Study Oxytocin - Behavioral

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Schizophrenia
• Oxytocin
• Social Cognition
• Psychotic Disorders

Interventions

Type	Name	Description
DRUG	Oxytocin	40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
DRUG	Saline Nasal Spray	40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Timeline

• Start date: 2010-10-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2015-10-02
• Last updated: 2020-02-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study