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Pharmacological Approach to Improve the Outcome of Social Cognition Training

NCT01517360 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2013-03-29

No results posted yet for this study

Summary

This study will evaluate whether oxytocin will facilitate the learning of social cognitive skills in schizophrenia patients who receive 12 sessions of Social Cognitive Skills Training (SCST). The primary hypothesis is that schizophrenia subjects who are treated with oxytocin will demonstrate greater improvements in a summary measure of social cognition than subjects treated with placebo over the course of SCST.

Conditions

Interventions

DRUG

Oxytocin

Oxytocin 40 IU, intranasal inhalation

OTHER

Placebo

Placebo, matched to Oxytocin, intranasal inhalation

BEHAVIORAL

Social Cognitive Skills Training

The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation. These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice. The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks. Each training session will last for about 90 minutes (1 hour training and 30 minutes between drug administration and start of training).

Sponsors & Collaborators

  • National Alliance for Research in Schizophrenia and Affective Disorders

    collaborator UNKNOWN

  • VA Greater Los Angeles Healthcare System

    lead FED

Principal Investigators

  • Stephen R Marder, MD · Department of Veterans Affairs, University of California Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517360 on ClinicalTrials.gov