Oxytocin MEG Study

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT02568709

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Oxytocin Magnetoencephalography (MEG) Social Cognition	Drug: Oxytocin Drug: Saline Nasal Spray	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effects of Oxytocin on Neural Activation Patterns During Social Cognitive Tasks in Patients With Schizophrenia

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Interventional 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
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

Arm

Intervention/Treatment

Active Comparator: Interventional

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

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

Outcome Measures

Primary Outcome Measures

Change in MEG neural activation patterns [Oxytocin and placebo administration days at least 1-week apart]
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 [Oxytocin and placebo administration days at least 1-week apart]
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 [Oxytocin and placebo administration days at least 1-week apart]
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 [1 day]
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 [1 day]
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) [1 day]
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) [1 day]
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) [1 day]
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 [1 day]
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) [1 day]
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) [1 day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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