Adult Study Oxytocin - fMRI (ASO-fMRI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02566356|
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : February 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Oxytocin Social Cognition Functional Magnetic Resonance Imaging (fMRI)||Drug: Oxytocin Drug: Saline Nasal Spray||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - fMRI|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
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 fMRI neural activation patterns [ Time Frame: 2-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 medial prefrontal cortex and the temporoparietal junction between placebo and oxytocin testing days using the fMRI 3T Siemens Skyra scanner.
- 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 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) [ 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.
- 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) [ 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.
- 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).
- Premorbid IQ test (AmNART) [ Time Frame: 1 day ]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) [ 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.
- 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).
- Kinsey Scale [ Time Frame: 1 day ]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) [ Time Frame: 1 day ]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.
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): NCT02566356
|United States, California|
|San Francisco Veterans Affairs Medical Center|
|San Francisco, California, United States, 94121|
|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|