Target Engagement for Oxytocin: Dose Ranging Study

NCT ID: NCT02498236

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-07-01

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.

Conditions

Schizophrenia Spectrum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Oxytocin 6-84 IU

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

Group Type: EXPERIMENTAL

Intranasal Oxytocin

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

Intranasal Oxytocin

Intervention Type: DRUG

Interventions

Intranasal Oxytocin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Serious medical condition or substance use
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Stephen R. Marder

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R21

Identifier Type: -

Identifier Source: org_study_id