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
About this trial
This is an interventional other trial for Schizophrenia Spectrum focused on measuring Psychosis, Schizophrenia, Oxytocin
Eligibility Criteria
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
NCT ID
NCT02498236
First Posted
July 13, 2015
Last Updated
January 11, 2019
Sponsor
University of California, Los Angeles
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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