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Adult Study Oxytocin - Behavioral (ASO-Behavioral)

Primary Purpose

Schizophrenia, Oxytocin, Social Cognition

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Saline Nasal Spray
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Oxytocin, Syntocinon, Social Cognition, Schizophrenia, Psychosis, Schizoaffective Disorder, Schizophreniform Disorder, Psychotic Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxytocin

Saline Nasal Spray

Arm Description

40 IU Oxytocin

Placebo Comparator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2015
Last Updated
February 25, 2020
Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02567032
Brief Title
Adult Study Oxytocin - Behavioral
Acronym
ASO-Behavioral
Official Title
Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Oxytocin, Social Cognition, Psychotic Disorders
Keywords
Oxytocin, Syntocinon, Social Cognition, Schizophrenia, Psychosis, Schizoaffective Disorder, Schizophreniform Disorder, Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
40 IU Oxytocin
Arm Title
Saline Nasal Spray
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Intervention Type
Drug
Intervention Name(s)
Saline Nasal Spray
Other Intervention Name(s)
Placebo
Intervention Description
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Primary Outcome Measure Information:
Title
Change in Social Cognition Task Performance
Description
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 Outcome Measure Information:
Title
Physiological Measurements
Description
Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks.
Time Frame
Through study completion, 2-3 weeks
Title
Questionnaire
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josh D Woolley, MD/PhD
Organizational Affiliation
University of California San Francisco, San Francisco Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Veterans Affairs Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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Adult Study Oxytocin - Behavioral

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