Target Engagement for Oxytocin: Dose Ranging Study

NCT02498236 | Completed Results

• 1 other identifier: R21
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia Spectrum

Keywords

Psychosis; Schizophrenia; Oxytocin

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Oxytocin 6-84 IU

EXPERIMENTAL

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

Drug: Intranasal Oxytocin

Placebo

PLACEBO COMPARATOR

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

Drug: Intranasal Oxytocin

Interventions

Intranasal Oxytocin DRUG

Oxytocin 6-84 IU; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Serious medical condition or substance use
• Pregnancy

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Stephen R. Marder
• Organization: University of California, Los Angeles

SMarder@mednet.ucla.edu

3104783711

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 15, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 31, 2019
• Results First Posted: January 31, 2019

Record last verified: 2019-01