Adult Study Oxytocin - Behavioral (ASO-Behavioral)

Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia; Oxytocin; Social Cognition
• Intervention / Treatment: Drug: Oxytocin; Drug: Saline Nasal Spray

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.

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • San Francisco, California, United States, 94121
      • San Francisco Veterans Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline Nasal Spray; Placebo Comparator	Drug: Saline Nasal Spray; 40 IU of the saline nasal spray will be administered once at the beginning of the visit.; Other Names: Placebo
Experimental: Oxytocin; 40 IU Oxytocin	Drug: Oxytocin; 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.; Other Names: Syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, 2-3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Measurements	Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks.	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.	At baseline visit, up to 4 hours

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: San Francisco Veterans Affairs Medical Center
• Investigators: Principal Investigator: Josh D Woolley, MD/PhD, University of California San Francisco, San Francisco Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 2, 2015

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Schizophrenia; Psychosis; Oxytocin; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorders; Social Cognition; Syntocinon
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 10-02262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No