Overview

This trial is active, not recruiting.

Conditions schizophrenia, oxytocin, magnetoencephalography (meg), social cognition
Treatments oxytocin, saline nasal spray
Phase phase 0
Sponsor University of California, San Francisco
Start date February 2012
End date December 2016
Trial size 40 participants
Trial identifier NCT02568709, 12-08411

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
40 IU Oxytocin
oxytocin Syntocinon
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
(Placebo Comparator)
Placebo Comparator
saline nasal spray Placebo
40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Primary Outcomes

Measure
Change in MEG neural activation patterns
time frame: Oxytocin and placebo administration days at least 1-week apart

Secondary Outcomes

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

Eligibility Criteria

Male participants from 18 years up to 40 years old.

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

Additional Information

Official title Effects of Oxytocin on Neural Activation Patterns During Social Cognitive Tasks in Patients With Schizophrenia
Principal investigator Josh D Woolley, MD/PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.