The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia
Overview
- Phase
- Early Phase 1
- Intervention
- Oxytocin
- Conditions
- Schizophrenia
- Sponsor
- University of California, San Francisco
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Improvement in social cognition task performance
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 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.
Investigators
Joshua Woolley
Principal Investigator
University of California, San Francisco
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Arms & Interventions
Oxytocin
40 IU Oxytocin
Intervention: Oxytocin
Saline Nasal Spray
Placebo Comparator
Intervention: Saline Nasal Spray
Outcomes
Primary Outcomes
Improvement in social cognition task performance
Time Frame: 2-days at least 1-week apart
The outcome will be the number of tasks that improve on the oxytocin day compared to the placebo day in a panel of tasks designed to measure the subject's level of social cognition. Participants will complete social cognition tasks, which include the Auction Task, Devil's Task, Ultimatum Task, Verbal Prosody, Effort Expenditure for Rewards Task (EEfRT), and Passive Viewing Eyetracking.
Secondary Outcomes
- Pre-morbid IQ Questionnaire (AmNART)(1 day)
- Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire(1 day)
- Childhood Trauma Questionnaire (CTQ)(1 day)
- Emotional Quotient Scale (EQS)(1 day)
- Kinsey Scale(1 day)
- Change in Working Memory capacity(2-days at least 1-week apart)
- Change in Auditory Perception correctness(2-days at least 1-week apart)
- Change in Auditory Perception reaction time(2-days at least 1-week apart)