Adult Oxytocin Study

Schizophrenia Clinical Trial

— OT  

Official title:

The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577575
• Other study ID #: 10-01508
• Status: Completed
• Phase: Early Phase 1
• Start date: August 2010
• Est. completion date: November 2015

Study information

• Verified date: May 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxytocin
• Schizophrenia
• Social Cognition

Intervention

Drug:
• Oxytocin
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
• Saline Nasal Spray
40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Locations

Country	Name	City	State
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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