Adult Oxytocin Study

Study 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.

Official Title
-----------------
The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia, Oxytocin, Social Cognition

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Drug: Saline Nasal Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>40 IU Oxytocin | Drug: Oxytocin<br>* 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.<br>* Other names: Syntocinon;|
| Placebo Comparator: Saline Nasal Spray<br>Placebo Comparator | Drug: Saline Nasal Spray<br>* 40 IU of the saline nasal spray will be administered once at the beginning of the visit.<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in social cognition task performance | 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. | 2-days at least 1-week apart | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-morbid IQ Questionnaire (AmNART) | The American National Adult Reading Test (AMNART) is an instrument used to estimate premorbid verbal intelligence quotient (IQ) in adults. Participants are shown 45 words one at a time and are asked to read the word aloud. The scorer then writes 0 if the participant read the word incorrectly or 1 if the pronunciation is correct. | 1 day | 
| Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire | The ECR is used to evaluate the construct of adult attachment. The scale involves 36 itemized statements split into four parts, each part referring to a different attachment figure. Participants rank each item using a 7-point likert scale. | 1 day | 
| Childhood Trauma Questionnaire (CTQ) | The CTQ is a brief survey of 6 early traumatic experiences, including death, divorce, violence, sexual abuse, illness or other. The scale determines and assesses an individual's understanding of their childhood trauma, if applicable. | 1 day | 
| Emotional Quotient Scale (EQS) | The EQ is a 60-item self-report questionnaire that is designed to measure empathy in adults. Participants use a 4 item likert scale to record their responses (1=definitely agree, 4= definitely disagree). | 1 day | 
| Kinsey Scale | The Kinsey scale attempts to describe a person's sexual orientation using a scale from 0 (i.e. heterosexual) to 6 (i.e. homosexual). | 1 day | 
| Change in Working Memory capacity | This task determines a participant's working memory capacity using the University of Maryland Letter Number Span Assessment. This asks 24 questions of increasing working memory difficulty and the total correct is calculated. Investigators will measure the change in the total correct between oxytocin and placebo days. | 2-days at least 1-week apart | 
| Change in Auditory Perception correctness | The Sound Sweeps task determines auditory perception ability by measuring changes in pitches to sounds. Investigators will measure the change in the total correct responses between oxytocin and placebo days. | 2-days at least 1-week apart | 
| Change in Auditory Perception reaction time | The Sound Sweeps task determines auditory perception ability by measuring changes in pitches to sounds. Investigators will measure the change in the reaction time between oxytocin and placebo days. | 2-days at least 1-week apart | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxytocin, Syntocinon, Social Cognition, Schizophrenia