Adult Study Oxytocin - Behavioral

Early Phase 1CompletedNCT02567032

University of California, San Francisco324 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

324

Conditions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria 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 Exclusion Criteria 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

Outcomes

Primary Outcomes

Change in Social Cognition Task Performance

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.

Time frame: Through study completion, 2-3 weeks

Secondary Outcomes

Physiological Measurements

Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks.

Time frame: Through study completion, 2-3 weeks

Questionnaire

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.

Time frame: At baseline visit, up to 4 hours