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Adult Study Oxytocin - Behavioral (ASO-Behavioral)

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ClinicalTrials.gov Identifier: NCT02567032
Recruitment Status : Recruiting
First Posted : October 2, 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

Tracking Information
First Submitted Date  ICMJE September 29, 2015
First Posted Date  ICMJE October 2, 2015
Last Update Posted Date May 21, 2019
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
Change in Social Cognition Task Performance [ Time Frame: Through study completion, 2-3 weeks ]
Participants will undergo computer tasks that measure social cognition. Tasks will involve verbal responses, pressing buttons at specific times, listening, and viewing audio-visual stimuli. Investigators will be measuring the difference in accuracy and verbal content of the responses on the oxytocin day compared to the placebo day.
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
Change in Social Cognition Task Performance [ Time Frame: 2-days at least 1-week apart ]
Participants will undergo tasks that measure social cognition, which include the Auction Task, Devil's Task, Ultimatum Task, Verbal Prosody, EEfRT, and Passive Viewing Eyetracking. This panel of tasks is designed to measure the subject's level of social cognition. Investigators will be measuring the number of tasks that improve on the oxytocin day compared to the placebo day.
Change History Complete list of historical versions of study NCT02567032 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
  • Physiological Measurements [ Time Frame: Through study completion, 2-3 weeks ]
    Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks.
  • Questionnaire [ Time Frame: At baseline visit, up to 4 hours ]
    Participants will be asked questions about their current positive and negative symptoms, medical and psychiatric history. Self-report responses will be saved in writing or audio recording.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
  • Pre-morbid IQ Questionnaire (AmNART) [ Time Frame: 1 day ]
    The American National Adult Reading Test (AMNART) is an instrument used to estimate premorbid verbal 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 [ 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • Change in Auditory Perception capabilities [ 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 and reaction time between oxytocin and placebo days.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adult Study Oxytocin - Behavioral
Official Title  ICMJE Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral
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 and other psychotic disorders. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders.

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.

Detailed Description Part 2: A supplementary study will be added to the proposed parent study, which includes additional behavioral testing consisting of several social cognition computer tasks, clinical assessments, physiological measurements, and questionnaires. The study will be conducted with the same study arms and study interventions as in the proposed parent study. For this supplementary study, the inclusion criteria has broadened to include patients with bipolar disorder with psychotic features and brief psychotic disorder.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Oxytocin
  • Social Cognition
  • Psychotic Disorders
Intervention  ICMJE
  • 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
  • Drug: Saline Nasal Spray
    40 IU of the saline nasal spray will be administered once at the beginning of the visit.
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Oxytocin
    40 IU Oxytocin
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Saline Nasal Spray
    Placebo Comparator
    Intervention: Drug: Saline Nasal Spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2018)
300
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
200
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Patients:

  • 18 to 45 years of age
  • Clinically stable
  • English Speaking
  • Meet DSM-5 criteria for schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder with psychotic features, or brief psychotic 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 45 years of age
  • Clinically stable
  • English Speaking
  • No diagnosis of mental disorder according to DSM-5, not including mild alcohol use disorder or mild cannabis use disorder
  • Able to use nasal spray
  • Must be capable of providing informed consent

Exclusion Criteria for Patients:

  • Active substance and alcohol use disorder in the past month as determined by the DSM-5 criteria, not including cannabis use disorder
  • Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
  • Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
  • Hearing deficits
  • Pregnancy
  • Severe brain trauma

Exclusion Criteria for Healthy Controls:

  • Active substance and moderate/severe alcohol use disorder, or mood disorder in the past month as determined by the DSM-5 criteria, not including mild alcohol use disorder or mild cannabis use disorder
  • Meet for a current psychiatric disorder according to DSM-5 criteria
  • Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
  • Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
  • Hearing deficits
  • Pregnancy
  • Severe brain trauma
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michelle Matvey, BA 415-221-4810 ext 23318 Michelle.Matvey@ucsf.edu
Contact: Jessica Buffington, BA 415-221-4810 ext 25164 Jessica.Buffington@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02567032
Other Study ID Numbers  ICMJE 10-02262
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joshua Woolley, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE San Francisco Veterans Affairs Medical Center
Investigators  ICMJE
Principal Investigator: Josh D Woolley, MD/PhD University of California San Francisco, San Francisco Veterans Affairs Medical Center
PRS Account University of California, San Francisco
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP