Target Engagement for Oxytocin: Dose Ranging Study

Schizophrenia Spectrum Clinical Trial

— R21Dose  

Official title:

Target Engagement for Oxytocin: Response to 8 Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498236
• Other study ID #: R21
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: July 1, 2017

Study information

• Verified date: January 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Schizophrenia, Schizoaffective Disorder, Delusional Disorder

• Able to cooperate with study procedures

Exclusion Criteria:

• Serious medical condition or substance use

• Pregnancy

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia Spectrum

Intervention

Drug:
• Intranasal Oxytocin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 1 Week
Primary	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.	Baseline, 1 Week