University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT02568709
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:
1. understand the pathophysiology of the functionally debilitating social cognitive deficits of schizophrenia, 2. test the efficacy of OT in normalizing the neural abnormalities underlying these social deficits, and 3. develop and optimize novel treatments for these currently untreatable deficits.
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Notify Me18 year–40 year
Male
Interventional
Early Phase 1
San Francisco, California, 94143, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Patients:
Inclusion criteria
for Healthy Controls:
Exclusion criteria
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Other names: Syntocinon
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other names: Placebo
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.
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.
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.
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").
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.
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.
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).
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).
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.
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.
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.
University of California, San Francisco
Other
Effects of Oxytocin on Neural Activation Patterns During Social Cognitive Tasks in Patients With Schizophrenia
Acronym: MEG
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