NCT01517360

Pharmacological Approach to Improve the Outcome of Social Cognition Training

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: VA Greater Los Angeles Healthcare System · Federal
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Individuals with schizophrenia often have serious deficits in their abilities to perceive and interpret socially relevant information. These deficits in social cognition can lead to misunderstanding the intentions of others and failing to interpret social signals that are important for successful social interactions. The relationship between social cognition and functioning has led our group to develop a research agenda that includes understanding the neural underpinnings of social cognitive deficits, measuring these impairments using brain-based biomarkers and clinical assessments, and enhancing our Social Cognitive Skills Training program to improve social cognition and promote recovery. Oxytocin, which is a hormone and neurotransmitter, is believed to impact social cognition through increased orienting toward and attending to socially salient visual features. There is also evidence that oxytocinergic signaling is impaired in schizophrenia. With this research, we hope to learn whether administration of oxytocin will improve different aspects of social cognition by examining the effects of oxytocin versus placebo administered intranasally before each of 12 sessions of a social cognitive skills training program on measures of independent living, work and social functioning.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-01-25
• Last updated: 2013-03-29

Locations

1 site across 1 country: United States