Adult Study Oxytocin - Behavioral

NCT ID: NCT02567032

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2019-08-31

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.

Conditions

Schizophrenia; Oxytocin; Social Cognition; Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oxytocin

40 IU Oxytocin

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

Saline Nasal Spray

Placebo Comparator

Group Type: PLACEBO_COMPARATOR

Saline Nasal Spray

Intervention Type: DRUG

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Interventions

Oxytocin

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

Intervention Type: DRUG

Saline Nasal Spray

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Intervention Type: DRUG

Other Intervention Names

Syntocinon; Placebo

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Joshua Woolley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josh D Woolley, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of California San Francisco, San Francisco Veterans Affairs Medical Center

Locations

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

10-02262

Identifier Type: -

Identifier Source: org_study_id