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Adult Oxytocin Study (OT)

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ClinicalTrials.gov Identifier: NCT02577575
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco

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

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Study Type : Interventional  (Clinical Trial)
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 : August 2010
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Oxytocin

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 Name: 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 Name: Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577575


Locations
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United States, California
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
San Francisco Veterans Affairs Medical Center
Investigators
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Principal Investigator: Joshua D Woolley, MD/PhD University of California San Francisco, San Francisco Veterans Affairs Medical Center

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Responsible Party: Joshua Woolley, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02577575     History of Changes
Other Study ID Numbers: 10-01508
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

Keywords provided by Joshua Woolley, University of California, San Francisco:
Oxytocin
Syntocinon
Social Cognition
Schizophrenia

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs