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Oxytocin MEG Study (MEG)

Primary Purpose

Schizophrenia, Oxytocin, Magnetoencephalography (MEG)

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, Magnetoencephalography (MEG)

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria for Patients:

  • 18-40 years of age
  • Male
  • Must comprehend English
  • Meet DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder
  • None or only minor changes to medications in the past week
  • Able to use nasal spray
  • Must be capable of providing informed consent
  • Clinically stable

Inclusion Criteria for Healthy Controls:

  • 18-40 years of age
  • Male
  • Must comprehend English
  • No diagnosis of mental disorder according to DSM-IV TR
  • Able to use nasal spray
  • Must be capable of providing informed consent
  • Clinically stable

Exclusion Criteria:

  • Female
  • Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
  • 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
  • A pacemaker, extensive dental work, or any magnetic metal implants
  • Any history of severe brain trauma

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Interventional

Saline Nasal Spray

Arm Description

40 IU Oxytocin

Placebo Comparator

Outcomes

Primary Outcome Measures

Change in MEG neural activation patterns
During tasks in which participants will see and hear various stimuli, investigators will measure the change in neural activity in the amygdala, the dorsal anterior cingulate cortex, as well as the fusiform gyrus using the MEG scanner.

Secondary Outcome Measures

Change in performance on Facial Recognition Task
In the Facial Recognition Task, subjects will be presented with various computerized emotional stimuli and will be asked to make a choice. Participants will then respond to the stimuli by pressing a either left or right on the control box and their reaction time will be measured.
Change in performance on International Affective Picture System (IAPS) task
In the IAPS Tasks, subjects will view images of people, objects, and scenes from the IAPS (International Affective Picture System). Participants will then respond by pressing a either left or right on the control box to chose a number from 1 (i.e. least disturbing) to 9 (i.e. most disturbing) and their reaction time will be measured.
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) 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.
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).
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).
Fagerstom Nicotine Dependence Test
The FNDT is the standard measure of an individual's physical addiction to nicotine. The test contains six items to evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.
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 this 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.

Full Information

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

Unique Protocol Identification Number
NCT02568709
Brief Title
Oxytocin MEG Study
Acronym
MEG
Official Title
Effects of Oxytocin on Neural Activation Patterns During Social Cognitive Tasks in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The specific aim of this proposal is to investigate the neurophysiological mechanisms of oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using magnetoencephalography. Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will be normalized. Hypothesis B: When OT is administered to patients with schizophrenia, the decreased functional connectivity (FC) between the amygdala, FG, and ACC will be normalized. By elucidating the neurophysiological mechanisms of OT administration on emotional face processing, investigators will bee able to: understand the pathophysiology of the functionally debilitating social cognitive deficits of schizophrenia, test the efficacy of OT in normalizing the neural abnormalities underlying these social deficits, and develop and optimize novel treatments for these currently untreatable deficits.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Active Comparator
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 MEG 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 amygdala, the dorsal anterior cingulate cortex, as well as the fusiform gyrus using the MEG scanner.
Time Frame
Oxytocin and placebo administration days at least 1-week apart
Secondary Outcome Measure Information:
Title
Change in performance on Facial Recognition Task
Description
In the Facial Recognition Task, subjects will be presented with various computerized emotional stimuli and will be asked to make a choice. Participants will then respond to the stimuli by pressing a either left or right on the control box and their reaction time will be measured.
Time Frame
Oxytocin and placebo administration days at least 1-week apart
Title
Change in performance on International Affective Picture System (IAPS) task
Description
In the IAPS Tasks, subjects will view images of people, objects, and scenes from the IAPS (International Affective Picture System). Participants will then respond by pressing a either left or right on the control box to chose a number from 1 (i.e. least disturbing) to 9 (i.e. most disturbing) and their reaction time will be measured.
Time Frame
Oxytocin and placebo administration days at least 1-week apart
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) 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
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
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
Fagerstom Nicotine Dependence Test
Description
The FNDT is the standard measure of an individual's physical addiction to nicotine. The test contains six items to evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.
Time Frame
1 day
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 this 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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Patients: 18-40 years of age Male Must comprehend English Meet DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder None or only minor changes to medications in the past week Able to use nasal spray Must be capable of providing informed consent Clinically stable Inclusion Criteria for Healthy Controls: 18-40 years of age Male Must comprehend English No diagnosis of mental disorder according to DSM-IV TR Able to use nasal spray Must be capable of providing informed consent Clinically stable Exclusion Criteria: Female Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening 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 A pacemaker, extensive dental work, or any magnetic metal implants Any history of 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
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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Oxytocin MEG Study

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