Target Engagement and Response to Oxytocin

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Behavioral: Health Management; Drug: Oxytocin nasal spray; Behavioral: Social Cognition Skills Training; Drug: Placebo nasal spray

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03245437

OT R33

R33MH107564 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.

Full description

The study will determine whether oxytocin (OT) administration 30 min before a training session enhances the learning of social information in the context of a social cognitive skills training (SCST) program, and it will test a possible mediator of this effect. Subjects with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial design: OT with SCST; Placebo with SCST; OT with training control condition; placebo with training control condition. Target engagement will be measured in an OT challenge (placebo versus OT one week apart) prior to baseline assessment. The measure of target engagement will be EEG mu suppression while observing biological motion. A social cognition battery will be administered at baseline, at midpoint after 6 weeks of SCST, and at completion of training at 12 weeks. The battery will include measures of social cue identification and mentalizing.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Schizophrenia or schizoaffective disorder
• stable on an antipsychotic medication

Exclusion criteria

• positive pregnancy test history of head injury

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Oxytocin with SCST

Experimental group

Description:

Oxytocin with SCST (active condition)

Treatment:

Behavioral: Social Cognition Skills Training

Drug: Oxytocin nasal spray

Oxytocin with Health Management

Sham Comparator group

Description:

Administration of OT with control psychosocial treatment

Treatment:

Drug: Oxytocin nasal spray

Behavioral: Health Management

Placebo with SCST

Placebo Comparator group

Description:

Administration of Placebo with active psychosocial treatment

Treatment:

Drug: Placebo nasal spray

Behavioral: Social Cognition Skills Training

Placebo with HM

Placebo Comparator group

Description:

Administration of Placebo with control psychosocial treatment

Treatment:

Drug: Placebo nasal spray

Behavioral: Health Management