Target Engagement for Oxytocin: Dose Ranging Study (R21Dose)

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Schizophrenia Spectrum

Treatments: Drug: Intranasal Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02498236

R21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Serious medical condition or substance use
• Pregnancy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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51 participants in 2 patient groups, including a placebo group

Oxytocin 6-84 IU

Experimental group

Description:

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

Treatment:

Drug: Intranasal Oxytocin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Intranasal Oxytocin