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Adult Oxytocin Study

The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02577575
Acronym
OT
Enrollment
120
Registered
2015-10-16
Start date
2010-08-31
Completion date
2015-11-30
Last updated
2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Oxytocin, Social Cognition

Keywords

Oxytocin, Syntocinon, Social Cognition, Schizophrenia

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.

Interventions

DRUGOxytocin

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

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

Sponsors

San Francisco Veterans Affairs Medical Center
CollaboratorFED
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in social cognition task performance2-days at least 1-week apartThe 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

MeasureTime frameDescription
Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire1 dayThe 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 dayThe 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 dayThe 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).
Pre-morbid IQ Questionnaire (AmNART)1 dayThe 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.
Change in Working Memory capacity2-days at least 1-week apartThis 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 correctness2-days at least 1-week apartThe 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 time2-days at least 1-week apartThe 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.
Kinsey Scale1 dayThe Kinsey scale attempts to describe a person's sexual orientation using a scale from 0 (i.e. heterosexual) to 6 (i.e. homosexual).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026