Adult Study Oxytocin - Behavioral

Early Phase 1

Completed

• Conditions: Schizophrenia; Oxytocin; Social Cognition; Psychotic Disorders
• Interventions: Drug: Saline Nasal Spray; Drug: Oxytocin

• Registration Number: NCT02567032
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 324

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline Nasal Spray	Saline Nasal Spray	Placebo Comparator
Oxytocin	Oxytocin	40 IU Oxytocin

Primary Outcome Measures

Name	Time	Method
Change in Social Cognition Task Performance	Through study completion, 2-3 weeks	Participants will undergo computer tasks that measure social cognition. Tasks will involve verbal responses, pressing buttons at specific times, listening, and viewing audio-visual stimuli. Investigators will be measuring the difference in accuracy and verbal content of the responses on the oxytocin day compared to the placebo day.

Secondary Outcome Measures

Name	Time	Method
Physiological Measurements	Through study completion, 2-3 weeks	Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks.
Questionnaire	At baseline visit, up to 4 hours	Participants will be asked questions about their current positive and negative symptoms, medical and psychiatric history. Self-report responses will be saved in writing or audio recording.

Trial Locations

Locations (2)

San Francisco Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States