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Completed

NCT Number: NCT01517360

Pharmacological Approach to Improve the Outcome of Social Cognition Training

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

West Los Angeles VA Medical Center

Los Angeles, California, 90073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition
  • Stable on an antipsychotic medication
  • No change in antipsychotic dose of >10% during the past 3 months

Exclusion criteria

  • Unable to provide informed consent
  • History of epilepsy
  • Active medical conditions that would make the study unsafe
  • History of serious head injury
  • History of hyponatremia

Treatment and study plan

Oxytocin

Drug

Oxytocin 40 IU, intranasal inhalation

Other names: Syntocinon

Placebo

Other

Placebo, matched to Oxytocin, intranasal inhalation

Social Cognitive Skills Training

Behavioral

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).

Primary outcomes

  1. Composite Social Cognition Score

    Time frame: Baseline, 6 weeks, and 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

VA Greater Los Angeles Healthcare System

Fed

Collaborators

  • National Alliance for Research in Schizophrenia and Affective Disorders

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2012
Registry last updated
Mar 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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