Pharmacological Approach to Improve the Outcome of Social Cognition Training

Status

Completed

Phase

Phase 1

Enrollment

27 participants (actual)

Sponsor

VA Greater Los Angeles Healthcare System · Fed

Design

Randomized · Quadruple masking

Countries

1 country

United States

Start

Jan 2012

Primary completion

Feb 2013

Completion

Feb 2013

First posted

25 Jan 2012 (estimated)

Last update posted

29 Mar 2013 (estimated)

Conditions

Schizophrenia

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.

• Active comparator

  Placebo+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. The treatment groups will include individuals who are assigned to placebo. Each training session will last for about 90 minutes (1 hour training and 30 minutes between placebo administration and start of training).

• Experimental

  Oxytocin+Social Cognitive Skill 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. The treatment groups will include individuals who are assigned to oxytocin. Each training session will last 90 minutes (1 hour training and 30 minutes between oxytocin administration and start of training).

1. Composite Social Cognition Score

   Time frame · Baseline, 6 weeks, and 10 weeks

   Registry description

   We will assess emotion management, emotion perception, social context processing/social perception, theory of mind, attributional bias, and empathic accuracy. The primary summary measure for each test will be mean-centered and standardized to create a Z-score that will be averaged to create a single composite score for social cognition, serving as the primary outcome measure. Parallel follow-up analyses will be conducted on individual components to determine which measures are most affected by treatment. Similar secondary analyses will be employed for the event related potential (ERP) and basic cognition measures.