Clinical trial NCT02566356: Adult Study Oxytocin - fMRI
Official title: Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - fMRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Oxytocin
Social Cognition
Functional Magnetic Resonance Imaging (fMRI)
Keywords: Oxytocin
Syntocinon
Social Cognition
Schizophrenia
Functional Magnetic Resonance Imaging (fMRI)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Veterans Affairs Medical Center
First posted: 2015-10-02
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in fMRI neural activation patterns
timeFrame: 2-days at least 1-week apart
Secondary outcomes:
measure: Quality of Life Scale (QLS)
timeFrame: 1 day
measure: Social Functioning Scale (SFS)
timeFrame: 1 day
measure: UCLA Loneliness Scale
timeFrame: 1 day
measure: Experiences in Close Relationships - Relationship Structures (ECR-RS)
timeFrame: 1 day
measure: Parental Bonding Instrument (PBI)
timeFrame: 1 day
measure: Premorbid IQ test (AmNART)
timeFrame: 1 day
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: 1 day
measure: Emotional Quotient Scale (EQS)
timeFrame: 1 day
measure: Kinsey Scale
timeFrame: 1 day
measure: Socioeconomic Status (SES)
timeFrame: 1 day
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California San Francisco, San Francisco Veterans Affairs Medical Center
name: Josh D Woolley, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: