Overview

This trial is active, not recruiting.

Conditions schizophrenia, oxytocin, social cognition
Treatments oxytocin, saline nasal spray
Phase phase 0
Sponsor University of California, San Francisco
Collaborator San Francisco Veterans Administration Medical Center
Start date August 2010
End date September 2014
Trial size 200 participants
Trial identifier NCT02577575, 10-01508

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 quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.

Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo.

Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.

Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (PNS) activity in patients with recent-onset schizophrenia.

Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS activity during social tasks after administration of oxytocin versus placebo.

Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their PNS activity.

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
(Experimental)
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
Improvement in social cognition task performance
time frame: 2-days at least 1-week apart

Secondary Outcomes

Measure
Pre-morbid IQ Questionnaire (AmNART)
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
Emotional Quotient Scale (EQS)
time frame: 1 day
Kinsey Scale
time frame: 1 day
Change in Working Memory capacity
time frame: 2-days at least 1-week apart
Change in Auditory Perception correctness
time frame: 2-days at least 1-week apart
Change in Auditory Perception reaction time
time frame: 2-days at least 1-week apart

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria for Patients: - 18 to 65 years of age - English Speaking - Meet Diagnostic and Statistical Manual (DSM)-IV criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder. - No or at most only minor changes to medications in the past week - Able to use nasal spray - Must be capable of providing informed consent Inclusion Criteria for healthy volunteers: - 18 to 65 years of age - Clinically stable - No diagnosis of mental disorder according to DSM-IV TR. - Able to use nasal spray - Must be capable of providing informed consent - English Speaking Exclusion Criteria: - Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening - A current 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 - Pregnancy - Severe brain trauma

Additional Information

Official title The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia
Principal investigator Joshua 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.