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Adult Study Oxytocin - fMRI (ASO-fMRI)

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, Functional Magnetic Resonance Imaging (fMRI)

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria for Patients:

  • Male
  • SCID-IV confirmed diagnosis of schizophrenia or schizoaffective disorder
  • Clinically stable
  • No changes to medications for the past week

Inclusion Criteria for Healthy Controls:

  • Male
  • SCID-IV confirmed no diagnosis of a current Axis I disorder within the last year

Exclusion Criteria for Patients and Healthy Controls:

  • Meeting criteria for current substance abuse or dependence or illicit drug use within the last month (nicotine use is acceptable) as determined by a Urine Toxicology Drug Screening
  • Any illness that affects the nasal passages and impairs the delivery of a nasal spray
  • Presence of any neurological or significant medical disorder, including medical illnesses that could interfere with physiological recording such as cardiac arrhythmias
  • A pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos
  • Pregnancy
  • Claustrophpbia
  • Hearing difficulties
  • A history of seizures
  • Failure to receive a passing score on the reading test

Additional Exclusion Criteria for Patients and Healthy Controls:

  • Taking any psychotropic medication or any medication that affects the autonomic or cardiovascular systems.
  • Schizophrenia or other psychotic disorder in a first degree relative
  • Failure to receive a passing score on the MOCA

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 fMRI neural activation patterns
During tasks in which participants will see and hear various stimuli, investigators will measure the change in neural activity in the medial prefrontal cortex and the temporoparietal junction between placebo and oxytocin testing days using the fMRI 3T Siemens Skyra scanner.

Secondary Outcome Measures

Quality of Life Scale (QLS)
The QLS is a 21-item clinical rating scale where the interviewer rates the participant's responses on a scale of 1-6 where 6 indicates no impairment. In the fMRI study an abbreviated version of the QLS is used that includes 9 of the 21 items. The 9 items are each derived from the sections examining interpersonal relations, occupational role functioning, intrapsychic foundations, and common objects.
Social Functioning Scale (SFS)
The SFS is designed to assess a subject's social skills and performance, and to measure functions that are of importance for schizophrenic patients. It is a 79-item scale completed by the subject.
UCLA Loneliness Scale
The UCLA Loneliness Scale assesses the loneliness level of participants. It is a 20-item scale where responses are measured from O ("I often feel this way") to N ("I never feel this way").
Experiences in Close Relationships - Relationship Structures (ECR-RS)
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.
Parental Bonding Instrument (PBI)
The PBI measures fundamental parenting styles as perceived the child. The questionnaire is retrospective in that it asks the adult participant to answer the questions based on how they remember their parents to be during up until they were 16 years old. The measure is completed for both mothers and fathers separately. There are 25 questions where half the questions are focused on how the parent cared for them and half are focused on how the parents protected them. A likert scale is used to measure responses where 1 is agree (i.e. very like) and 4 is disagree (i.e. very dislike).
Premorbid IQ test (AmNART)
The American National Adult Reading Test (AMNART) is an instrument used to estimate premorbid verbal 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.
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).
Socioeconomic Status (SES)
This assess participants' socioeconomic status through their educational level and occupational level using a scale from 1 (i.e. professional, higher executive level) to 7 (i.e. less than 7 years of school, unskilled employee). This scale is also used for the participants' primary and secondary caretakers.

Full Information

First Posted
September 30, 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
NCT02566356
Brief Title
Adult Study Oxytocin - fMRI
Acronym
ASO-fMRI
Official Title
Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - fMRI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (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 examine the effects of exogenous oxytocin on patterns of neural activation as measured by fMRI during a well-characterized affect-labeling task in patients with recent-onset schizophrenia and healthy comparison subjects. Hypothesis A: Patients will exhibit amygdalar hyperactivity and PNS hypo-activity when passively viewing faces, which will be normalized by administration of oxytocin. Hypothesis B: Patients will exhibit hypo-activity of the vPFC when affectively labeling faces and this hypo-activity will be normalized by oxytocin administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Oxytocin, Social Cognition, Functional Magnetic Resonance Imaging (fMRI)
Keywords
Oxytocin, Syntocinon, Social Cognition, Schizophrenia, Functional Magnetic Resonance Imaging (fMRI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (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 fMRI neural activation patterns
Description
During tasks in which participants will see and hear various stimuli, investigators will measure the change in neural activity in the medial prefrontal cortex and the temporoparietal junction between placebo and oxytocin testing days using the fMRI 3T Siemens Skyra scanner.
Time Frame
2-days at least 1-week apart
Secondary Outcome Measure Information:
Title
Quality of Life Scale (QLS)
Description
The QLS is a 21-item clinical rating scale where the interviewer rates the participant's responses on a scale of 1-6 where 6 indicates no impairment. In the fMRI study an abbreviated version of the QLS is used that includes 9 of the 21 items. The 9 items are each derived from the sections examining interpersonal relations, occupational role functioning, intrapsychic foundations, and common objects.
Time Frame
1 day
Title
Social Functioning Scale (SFS)
Description
The SFS is designed to assess a subject's social skills and performance, and to measure functions that are of importance for schizophrenic patients. It is a 79-item scale completed by the subject.
Time Frame
1 day
Title
UCLA Loneliness Scale
Description
The UCLA Loneliness Scale assesses the loneliness level of participants. It is a 20-item scale where responses are measured from O ("I often feel this way") to N ("I never feel this way").
Time Frame
1 day
Title
Experiences in Close Relationships - Relationship Structures (ECR-RS)
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
Parental Bonding Instrument (PBI)
Description
The PBI measures fundamental parenting styles as perceived the child. The questionnaire is retrospective in that it asks the adult participant to answer the questions based on how they remember their parents to be during up until they were 16 years old. The measure is completed for both mothers and fathers separately. There are 25 questions where half the questions are focused on how the parent cared for them and half are focused on how the parents protected them. A likert scale is used to measure responses where 1 is agree (i.e. very like) and 4 is disagree (i.e. very dislike).
Time Frame
1 day
Title
Premorbid IQ test (AmNART)
Description
The American National Adult Reading Test (AMNART) is an instrument used to estimate premorbid verbal 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
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
Socioeconomic Status (SES)
Description
This assess participants' socioeconomic status through their educational level and occupational level using a scale from 1 (i.e. professional, higher executive level) to 7 (i.e. less than 7 years of school, unskilled employee). This scale is also used for the participants' primary and secondary caretakers.
Time Frame
1 day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Patients: Male SCID-IV confirmed diagnosis of schizophrenia or schizoaffective disorder Clinically stable No changes to medications for the past week Inclusion Criteria for Healthy Controls: Male SCID-IV confirmed no diagnosis of a current Axis I disorder within the last year Exclusion Criteria for Patients and Healthy Controls: Meeting criteria for current substance abuse or dependence or illicit drug use within the last month (nicotine use is acceptable) as determined by a Urine Toxicology Drug Screening Any illness that affects the nasal passages and impairs the delivery of a nasal spray Presence of any neurological or significant medical disorder, including medical illnesses that could interfere with physiological recording such as cardiac arrhythmias A pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos Pregnancy Claustrophpbia Hearing difficulties A history of seizures Failure to receive a passing score on the reading test Additional Exclusion Criteria for Patients and Healthy Controls: Taking any psychotropic medication or any medication that affects the autonomic or cardiovascular systems. Schizophrenia or other psychotic disorder in a first degree relative Failure to receive a passing score on the MOCA
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 - fMRI

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