ASO-fMRI: Adult Study Oxytocin - fMRI

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT02566356

Collaborator

San Francisco Veterans Affairs Medical Center (U.S. Fed)

Enrollment

Locations

Arms

Duration (Months)

29.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - fMRI

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oxytocin 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

Experimental: Oxytocin

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 fMRI neural activation patterns [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.

Secondary Outcome Measures

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 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) [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 [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) [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) [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) [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) [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) [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 [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for Patients:

Male
SCID-IV confirmed diagnosis of schizophrenia or schizoaffective disorder
Clinically stable
No changes to medications for the past week

Inclusion Criteria for Healthy Controls:

Male
SCID-IV confirmed no diagnosis of a current Axis I disorder within the last year

Exclusion Criteria for Patients and Healthy Controls:

Meeting criteria for current substance abuse or dependence or illicit drug use within the last month (nicotine use is acceptable) as determined by a Urine Toxicology Drug Screening
Any illness that affects the nasal passages and impairs the delivery of a nasal spray
Presence of any neurological or significant medical disorder, including medical illnesses that could interfere with physiological recording such as cardiac arrhythmias
A pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos
Pregnancy
Claustrophpbia
Hearing difficulties
A history of seizures
Failure to receive a passing score on the reading test

Additional Exclusion Criteria for Patients and Healthy Controls:

Taking any psychotropic medication or any medication that affects the autonomic or cardiovascular systems.
Schizophrenia or other psychotic disorder in a first degree relative
Failure to receive a passing score on the MOCA

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco Veterans Affairs Medical Center	San Francisco	California	United States	94121
2	University of California, San Francisco	San Francisco	California	United States	94143