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Target Engagement for Oxytocin: Dose Ranging Study (R21Dose)

Primary Purpose

Schizophrenia Spectrum

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intranasal Oxytocin
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia Spectrum focused on measuring Psychosis, Schizophrenia, Oxytocin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Schizophrenia, Schizoaffective Disorder, Delusional Disorder
  • Able to cooperate with study procedures

Exclusion Criteria:

  • Serious medical condition or substance use
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Oxytocin 6-84 IU

    Placebo

    Arm Description

    Subjects will be randomly assigned to one of eight doses of intranasal oxytocin.

    Subjects will be administered intranasal placebo using the same spray volume as experimental condition

    Outcomes

    Primary Outcome Measures

    Mu Suppression on EEG
    This primary outcome measure is mu suppression recorded during a biological motion task. In this task, participants view point-light walker (PLW) animations of a human; the PLWs were either male or female, happy or sad, or walking towards or away from the viewer. In addition to the humans, there was a control condition which consisted of a circle moving either left or right. In separate blocks, participants had to identify either the gender, the emotion, or intention (i.e., direction) of the walker, or the direction of the circle, while their EEG was recorded. The primary measure was mu activity (8-12 Hz) recorded over 3 central electrodes. Mu suppression was calculated as the log10 transformed ratio of mu power to one of the three human conditions compared to the circle: log10(human/circle). A negative value indicates suppression of mu activity to human walkers vs. circles. We are presenting the mean (SD) of this suppression ratio collapsed over the 3 human conditions.
    Pupil Dilation While Observing Faces
    This primary outcome measure is pupil size recorded during a facial affect identification task. In this task, participants view faces portraying happy, afraid, or neutral faces; scrambled images of the faces were also shown. There were 64 trials: 16 trials per each image type. The primary measure was the difference in pupil size averaged over the happy and fearful faces from the scrambled face condition. A positive value indicates greater pupil dilation relative to the scrambled face; a negative value indicates greater pupil constriction relative to the scrambled face. Baseline was defined as the median pupil width 1 second prior to stimulus onset. Pupil sizes during each trial were baseline-corrected by dividing them by baseline median width. Resulting pupil size timecourses were averaged within-subject for each type of stimulus (happy, afraid, neutral, scrambled). The primary dependent variable was computed by taking the average of the change in pupil size between 1 and 3 s.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 13, 2015
    Last Updated
    January 11, 2019
    Sponsor
    University of California, Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02498236
    Brief Title
    Target Engagement for Oxytocin: Dose Ranging Study
    Acronym
    R21Dose
    Official Title
    Target Engagement for Oxytocin: Response to 8 Doses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    July 1, 2017 (Actual)
    Study Completion Date
    July 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will evaluate the effect of 8 doses of intranasal oxytocin or placebo on two proposed measures of target engagement in brain. The targets are (1) the suppression of a particular wave form (mu) on the electroencephalogram (EEG) while subjects observe a socially relevant form of motion and (2) pupil dilation will subjects identify faces showing different emotions.
    Detailed Description
    Subjects with schizophrenia spectrum disorders will be randomly assigned to one of 8 doses of oxytocin. After screening and informed consent subjects will receive either their assigned dose or a placebo. Thirty minutes following the drug administration patients will be evaluated on the EEG and pupillometry tasks followed by two tests that evaluate social salience. One week later subjects will have a second challenge in the alternative (drug or placebo) condition.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia Spectrum
    Keywords
    Psychosis, Schizophrenia, Oxytocin

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oxytocin 6-84 IU
    Arm Type
    Experimental
    Arm Description
    Subjects will be randomly assigned to one of eight doses of intranasal oxytocin.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will be administered intranasal placebo using the same spray volume as experimental condition
    Intervention Type
    Drug
    Intervention Name(s)
    Intranasal Oxytocin
    Primary Outcome Measure Information:
    Title
    Mu Suppression on EEG
    Description
    This primary outcome measure is mu suppression recorded during a biological motion task. In this task, participants view point-light walker (PLW) animations of a human; the PLWs were either male or female, happy or sad, or walking towards or away from the viewer. In addition to the humans, there was a control condition which consisted of a circle moving either left or right. In separate blocks, participants had to identify either the gender, the emotion, or intention (i.e., direction) of the walker, or the direction of the circle, while their EEG was recorded. The primary measure was mu activity (8-12 Hz) recorded over 3 central electrodes. Mu suppression was calculated as the log10 transformed ratio of mu power to one of the three human conditions compared to the circle: log10(human/circle). A negative value indicates suppression of mu activity to human walkers vs. circles. We are presenting the mean (SD) of this suppression ratio collapsed over the 3 human conditions.
    Time Frame
    Baseline, 1 Week
    Title
    Pupil Dilation While Observing Faces
    Description
    This primary outcome measure is pupil size recorded during a facial affect identification task. In this task, participants view faces portraying happy, afraid, or neutral faces; scrambled images of the faces were also shown. There were 64 trials: 16 trials per each image type. The primary measure was the difference in pupil size averaged over the happy and fearful faces from the scrambled face condition. A positive value indicates greater pupil dilation relative to the scrambled face; a negative value indicates greater pupil constriction relative to the scrambled face. Baseline was defined as the median pupil width 1 second prior to stimulus onset. Pupil sizes during each trial were baseline-corrected by dividing them by baseline median width. Resulting pupil size timecourses were averaged within-subject for each type of stimulus (happy, afraid, neutral, scrambled). The primary dependent variable was computed by taking the average of the change in pupil size between 1 and 3 s.
    Time Frame
    Baseline, 1 Week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Schizophrenia, Schizoaffective Disorder, Delusional Disorder Able to cooperate with study procedures Exclusion Criteria: Serious medical condition or substance use Pregnancy

    12. IPD Sharing Statement

    Learn more about this trial

    Target Engagement for Oxytocin: Dose Ranging Study

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