Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral
Overview
- Phase
- Early Phase 1
- Intervention
- Oxytocin
- Conditions
- Schizophrenia
- Sponsor
- University of California, San Francisco
- Enrollment
- 324
- Locations
- 2
- Primary Endpoint
- Change in Social Cognition Task Performance
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Joshua Woolley
Principal Investigator
University of California, San Francisco
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Oxytocin
40 IU Oxytocin
Intervention: Oxytocin
Saline Nasal Spray
Placebo Comparator
Intervention: Saline Nasal Spray
Outcomes
Primary Outcomes
Change in Social Cognition Task Performance
Time Frame: 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 Outcomes
- Physiological Measurements(Through study completion, 2-3 weeks)
- Questionnaire(At baseline visit, up to 4 hours)