Oxytocin MEG Study (MEG)
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|ClinicalTrials.gov Identifier: NCT02568709|
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : May 21, 2019
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Oxytocin on Neural Activation Patterns During Social Cognitive Tasks in Patients With Schizophrenia|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: Interventional
40 IU Oxytocin
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Other Name: Syntocinon
Placebo Comparator: Saline Nasal Spray
Drug: Saline Nasal Spray
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other Name: Placebo
- Change in MEG neural activation patterns [ Time Frame: 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.
- Change in performance on Facial Recognition Task [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568709
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Josh D Woolley, MD/PhD||University of California San Francisco, San Francisco Veterans Affairs Medical Center|