Target Engagement for Oxytocin: Dose Ranging Study

Not Applicable

Completed

• Conditions: Schizophrenia Spectrum
• Interventions: Drug: Intranasal Oxytocin

• Registration Number: NCT02498236
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-15
• Study Start: 2015-09
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Results First Submitted: 2018-07-25
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-11
• Last Update Submitted: 2019-01-11
• Results First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

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Exclusion Criteria

• Serious medical condition or substance use
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Intranasal Oxytocin	Subjects will be administered intranasal placebo using the same spray volume as experimental condition
Oxytocin 6-84 IU	Intranasal Oxytocin	Subjects will be randomly assigned to one of eight doses of intranasal oxytocin.

Primary Outcome Measures

Name	Time	Method
Pupil Dilation While Observing Faces	Baseline, 1 Week	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.
Mu Suppression on EEG	Baseline, 1 Week	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.