Clinical trial NCT02568709: Oxytocin MEG Study
Official title: Effects of Oxytocin on Neural Activation Patterns During Social Cognitive Tasks in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Oxytocin
Magnetoencephalography (MEG)
Social Cognition
Keywords: Oxytocin
Syntocinon
Social Cognition
Schizophrenia
Magnetoencephalography (MEG)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria for Patients:

* 18-40 years of age
* Male
* Must comprehend English
* Meet DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder
* None or only minor changes to medications in the past week
* Able to use nasal spray
* Must be capable of providing informed consent
* Clinically stable

Inclusion Criteria for Healthy Controls:

* 18-40 years of age
* Male
* Must comprehend English
* No diagnosis of mental disorder according to DSM-IV TR
* Able to use nasal spray
* Must be capable of providing informed consent
* Clinically stable

Exclusion Criteria:

* Female
* Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
* DSM-IV diagnosis of any disorder other than schizophrenia
* Medical conditions (atrophic rhinitis, recurrent nose bleeds and cranial surgical procedures (hypophysectomy), congestion or sinus problems that could interfere with the study as per the opinion of the investigator
* Hearing deficits
* A pacemaker, extensive dental work, or any magnetic metal implants
* Any history of severe brain trauma

Primary outcomes:
measure: Change in MEG neural activation patterns
timeFrame: Oxytocin and placebo administration days at least 1-week apart
Secondary outcomes:
measure: Change in performance on Facial Recognition Task
timeFrame: Oxytocin and placebo administration days at least 1-week apart
measure: Change in performance on International Affective Picture System (IAPS) task
timeFrame: Oxytocin and placebo administration days at least 1-week apart
measure: UCLA Loneliness Scale
timeFrame: 1 day
measure: Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire
timeFrame: 1 day
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: 1 day
measure: Parental Bonding Instrument (PBI)
timeFrame: 1 day
measure: Emotional Quotient Scale (EQS)
timeFrame: 1 day
measure: Fagerstom Nicotine Dependence Test
timeFrame: 1 day
measure: Quality of Life Scale (QLS)
timeFrame: 1 day
measure: Social Functioning Scale (SFS)
timeFrame: 1 day
Other outcomes:
Locations:
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: