Target Engagement and Response to Oxytocin

NCT ID: NCT03245437

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-Blind Placebo controlled

Study Groups

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Oxytocin with SCST

Oxytocin with SCST (active condition)

Group Type EXPERIMENTAL

Oxytocin nasal spray

Intervention Type DRUG

nasal spray

Social Cognition Skills Training

Intervention Type BEHAVIORAL

Group based training in social cognition skills

Oxytocin with Health Management

Administration of OT with control psychosocial treatment

Group Type SHAM_COMPARATOR

Oxytocin nasal spray

Intervention Type DRUG

nasal spray

Health Management

Intervention Type BEHAVIORAL

Group-based training in mental health management

Placebo with SCST

Administration of Placebo with active psychosocial treatment

Group Type PLACEBO_COMPARATOR

Social Cognition Skills Training

Intervention Type BEHAVIORAL

Group based training in social cognition skills

Placebo nasal spray

Intervention Type DRUG

placebo condition

Placebo with HM

Administration of Placebo with control psychosocial treatment

Group Type PLACEBO_COMPARATOR

Health Management

Intervention Type BEHAVIORAL

Group-based training in mental health management

Placebo nasal spray

Intervention Type DRUG

placebo condition

Interventions

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Oxytocin nasal spray

nasal spray

Intervention Type DRUG

Social Cognition Skills Training

Group based training in social cognition skills

Intervention Type BEHAVIORAL

Health Management

Group-based training in mental health management

Intervention Type BEHAVIORAL

Placebo nasal spray

placebo condition

Intervention Type DRUG

Other Intervention Names

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OT SCST HM PBO

Eligibility Criteria

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Inclusion Criteria

* Schizophrenia or schizoaffective disorder
* stable on an antipsychotic medication

Exclusion Criteria

* positive pregnancy test history of head injury
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Stephen R. Marder

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen Marder, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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R33MH107564

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OT R33

Identifier Type: -

Identifier Source: org_study_id

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