Adult Study Oxytocin - Behavioral (ASO-Behavioral)

University of California San Francisco (UCSF)

Status and phase

Completed

Early Phase 1

Conditions

Psychotic Disorders

Schizophrenia

Oxytocin

Social Cognition

Treatments

Drug: Saline Nasal Spray

Drug: Oxytocin

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT02567032

10-02262

Details and patient eligibility

About

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.

Full 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.

Enrollment

324 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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