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Completed

NCT Number: NCT02577575

Adult Oxytocin Study

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.

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Key information

Conditions

Schizophrenia Mental Disorders Oxytocin Schizophrenia Spectrum and Other Psychotic Disorders Social Cognition

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

San Francisco Veterans Affairs Medical Center, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

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

Other names: Syntocinon

Saline Nasal Spray

Drug

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

Other names: Placebo

Primary outcomes

  1. 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

  1. Pre-morbid IQ Questionnaire (AmNART)

    Time frame: 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.

  2. Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire

    Time frame: 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.

  3. Childhood Trauma Questionnaire (CTQ)

    Time frame: 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.

  4. Emotional Quotient Scale (EQS)

    Time frame: 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).

  5. Kinsey Scale

    Time frame: 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).

  6. Change in Working Memory capacity

    Time frame: 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.

  7. Change in Auditory Perception correctness

    Time frame: 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.

  8. Change in Auditory Perception reaction time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco Veterans Affairs Medical Center

Registry information

Official study title

The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia

Acronym: OT

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2015
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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