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Adult Oxytocin Study (OT)

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Patients:

  • 18 to 65 years of age
  • English Speaking
  • Meet Diagnostic and Statistical Manual (DSM)-IV criteria for schizophrenia, schizoaffective disorder, schizophreniform 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 65 years of age
  • Clinically stable
  • No diagnosis of mental disorder according to DSM-IV TR.
  • Able to use nasal spray
  • Must be capable of providing informed consent
  • English Speaking

Exclusion Criteria:

  • Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
  • A current DSM-IV diagnosis of any disorder other than schizophrenia
  • Medical conditions (atrophic rhinitis, recurrent nose bleeds and cranial-surgical procedures (hypophysectomy), 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

Improvement in social cognition task performance
The outcome will be the number of tasks that improve on the oxytocin day compared to the placebo day in a panel of tasks designed to measure the subject's level of social cognition. Participants will complete social cognition tasks, which include the Auction Task, Devil's Task, Ultimatum Task, Verbal Prosody, Effort Expenditure for Rewards Task (EEfRT), and Passive Viewing Eyetracking.

Secondary Outcome Measures

Pre-morbid IQ Questionnaire (AmNART)
The American National Adult Reading Test (AMNART) is an instrument used to estimate premorbid verbal intelligence quotient (IQ) in adults. Participants are shown 45 words one at a time and are asked to read the word aloud. The scorer then writes 0 if the participant read the word incorrectly or 1 if the pronunciation is correct.
Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire
The ECR is used to evaluate the construct of adult attachment. The scale involves 36 itemized statements split into four parts, each part referring to a different attachment figure. Participants rank each item using a 7-point likert scale.
Childhood Trauma Questionnaire (CTQ)
The CTQ is a brief survey of 6 early traumatic experiences, including death, divorce, violence, sexual abuse, illness or other. The scale determines and assesses an individual's understanding of their childhood trauma, if applicable.
Emotional Quotient Scale (EQS)
The EQ is a 60-item self-report questionnaire that is designed to measure empathy in adults. Participants use a 4 item likert scale to record their responses (1=definitely agree, 4= definitely disagree).
Kinsey Scale
The Kinsey scale attempts to describe a person's sexual orientation using a scale from 0 (i.e. heterosexual) to 6 (i.e. homosexual).
Change in Working Memory capacity
This task determines a participant's working memory capacity using the University of Maryland Letter Number Span Assessment. This asks 24 questions of increasing working memory difficulty and the total correct is calculated. Investigators will measure the change in the total correct between oxytocin and placebo days.
Change in Auditory Perception correctness
The Sound Sweeps task determines auditory perception ability by measuring changes in pitches to sounds. Investigators will measure the change in the total correct responses between oxytocin and placebo days.
Change in Auditory Perception reaction time
The Sound Sweeps task determines auditory perception ability by measuring changes in pitches to sounds. Investigators will measure the change in the reaction time between oxytocin and placebo days.

Full Information

First Posted
September 29, 2015
Last Updated
May 17, 2019
Sponsor
University of California, San Francisco
Collaborators
San Francisco Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02577575
Brief Title
Adult Oxytocin Study
Acronym
OT
Official Title
The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (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

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. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia. 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. Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (PNS) activity in patients with recent-onset schizophrenia. Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS activity during social tasks after administration of oxytocin versus placebo. Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their PNS activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Oxytocin, Social Cognition
Keywords
Oxytocin, Syntocinon, Social Cognition, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (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
Improvement in social cognition task performance
Description
The outcome will be the number of tasks that improve on the oxytocin day compared to the placebo day in a panel of tasks designed to measure the subject's level of social cognition. Participants will complete social cognition tasks, which include the Auction Task, Devil's Task, Ultimatum Task, Verbal Prosody, Effort Expenditure for Rewards Task (EEfRT), and Passive Viewing Eyetracking.
Time Frame
2-days at least 1-week apart
Secondary Outcome Measure Information:
Title
Pre-morbid IQ Questionnaire (AmNART)
Description
The American National Adult Reading Test (AMNART) is an instrument used to estimate premorbid verbal intelligence quotient (IQ) in adults. Participants are shown 45 words one at a time and are asked to read the word aloud. The scorer then writes 0 if the participant read the word incorrectly or 1 if the pronunciation is correct.
Time Frame
1 day
Title
Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire
Description
The ECR is used to evaluate the construct of adult attachment. The scale involves 36 itemized statements split into four parts, each part referring to a different attachment figure. Participants rank each item using a 7-point likert scale.
Time Frame
1 day
Title
Childhood Trauma Questionnaire (CTQ)
Description
The CTQ is a brief survey of 6 early traumatic experiences, including death, divorce, violence, sexual abuse, illness or other. The scale determines and assesses an individual's understanding of their childhood trauma, if applicable.
Time Frame
1 day
Title
Emotional Quotient Scale (EQS)
Description
The EQ is a 60-item self-report questionnaire that is designed to measure empathy in adults. Participants use a 4 item likert scale to record their responses (1=definitely agree, 4= definitely disagree).
Time Frame
1 day
Title
Kinsey Scale
Description
The Kinsey scale attempts to describe a person's sexual orientation using a scale from 0 (i.e. heterosexual) to 6 (i.e. homosexual).
Time Frame
1 day
Title
Change in Working Memory capacity
Description
This task determines a participant's working memory capacity using the University of Maryland Letter Number Span Assessment. This asks 24 questions of increasing working memory difficulty and the total correct is calculated. Investigators will measure the change in the total correct between oxytocin and placebo days.
Time Frame
2-days at least 1-week apart
Title
Change in Auditory Perception correctness
Description
The Sound Sweeps task determines auditory perception ability by measuring changes in pitches to sounds. Investigators will measure the change in the total correct responses between oxytocin and placebo days.
Time Frame
2-days at least 1-week apart
Title
Change in Auditory Perception reaction time
Description
The Sound Sweeps task determines auditory perception ability by measuring changes in pitches to sounds. Investigators will measure the change in the reaction time between oxytocin and placebo days.
Time Frame
2-days at least 1-week apart

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Patients: 18 to 65 years of age English Speaking Meet Diagnostic and Statistical Manual (DSM)-IV criteria for schizophrenia, schizoaffective disorder, schizophreniform 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 65 years of age Clinically stable No diagnosis of mental disorder according to DSM-IV TR. Able to use nasal spray Must be capable of providing informed consent English Speaking Exclusion Criteria: Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening A current DSM-IV diagnosis of any disorder other than schizophrenia Medical conditions (atrophic rhinitis, recurrent nose bleeds and cranial-surgical procedures (hypophysectomy), 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
Joshua 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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