Adult Study Oxytocin - fMRI

Schizophrenia Clinical Trial

— ASO-fMRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566356
• Other study ID #: 12-09654
• Status: Completed
• Phase: Early Phase 1
• Start date: September 2012
• Est. completion date: September 2017

Study information

• Verified date: May 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Functional Magnetic Resonance Imaging (fMRI)
• Oxytocin
• Schizophrenia
• Social Cognition

Intervention

Drug:
• Oxytocin
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
• Saline Nasal Spray
40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Locations

Country	Name	City	State
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fMRI neural activation patterns	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.	2-days at least 1-week apart
Secondary	Quality of Life Scale (QLS)	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.	1 day
Secondary	Social Functioning Scale (SFS)	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.	1 day
Secondary	UCLA Loneliness Scale	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").	1 day
Secondary	Experiences in Close Relationships - Relationship Structures (ECR-RS)	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.	1 day
Secondary	Parental Bonding Instrument (PBI)	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).	1 day
Secondary	Premorbid IQ test (AmNART)	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.	1 day
Secondary	Childhood Trauma Questionnaire (CTQ)	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.	1 day
Secondary	Emotional Quotient Scale (EQS)	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).	1 day
Secondary	Kinsey Scale	The Kinsey scale attempts to describe a person's sexual orientation using a scale from 0 (i.e. heterosexual) to 6 (i.e. homosexual).	1 day
Secondary	Socioeconomic Status (SES)	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.	1 day