Adult Study Oxytocin - Behavioral

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: San Francisco Veterans Affairs Medical Center
• Treatments: Oxytocin

Criteria

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