OT: Adult Oxytocin Study

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT02577575

Collaborator

San Francisco Veterans Affairs Medical Center (U.S. Fed)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Oxytocin Social Cognition	Drug: Oxytocin Drug: Saline Nasal Spray	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oxytocin 40 IU Oxytocin	Drug: Oxytocin 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit. Other Names: Syntocinon
Placebo Comparator: Saline Nasal Spray Placebo Comparator	Drug: Saline Nasal Spray 40 IU of the saline nasal spray will be administered once at the beginning of the visit. Other Names: Placebo

Arm

Intervention/Treatment

Experimental: Oxytocin

40 IU Oxytocin

Drug: Oxytocin

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

Other Names:

Syntocinon

Placebo Comparator: Saline Nasal Spray

Placebo Comparator

Drug: Saline Nasal Spray

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Improvement in social cognition task performance [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 Outcome Measures

Pre-morbid IQ Questionnaire (AmNART) [1 day]
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.
Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire [1 day]
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.
Childhood Trauma Questionnaire (CTQ) [1 day]
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.
Emotional Quotient Scale (EQS) [1 day]
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).
Kinsey Scale [1 day]
The Kinsey scale attempts to describe a person's sexual orientation using a scale from 0 (i.e. heterosexual) to 6 (i.e. homosexual).
Change in Working Memory capacity [2-days at least 1-week apart]
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.
Change in Auditory Perception correctness [2-days at least 1-week apart]
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.
Change in Auditory Perception reaction time [2-days at least 1-week apart]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco Veterans Affairs Medical Center	San Francisco	California	United States	94121
2	University of California, San Francisco	San Francisco	California	United States	94143