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Pharmacological Approach to Improve the Outcome of Social Cognition Training

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research in Schizophrenia and Affective Disorders
Information provided by (Responsible Party):
Stephen R Marder, MD, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier:
NCT01517360
First received: January 19, 2012
Last updated: March 27, 2013
Last verified: March 2013
History of Changes

January 19, 2012
March 27, 2013
January 2012
February 2013   (final data collection date for primary outcome measure)
Composite Social Cognition Score [ Time Frame: Baseline, 6 weeks, and 10 weeks ] [ Designated as safety issue: No ]
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.
Composite Social Cognition Score [ Time Frame: Baseline, 6 weeks, and 10 weeks ] [ Designated as safety issue: No ]
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 ERP and basic cognition measures.
Complete list of historical versions of study NCT01517360 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Pharmacological Approach to Improve the Outcome of Social Cognition Training
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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Oxytocin
    Oxytocin 40 IU, intranasal inhalation
    Other Names:
    • Oxytocin
    • Syntocinon
  • 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).
  • 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).
    Interventions:
    • Other: Placebo
    • Behavioral: Social Cognitive Skills 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).
    Interventions:
    • Drug: Oxytocin
    • Behavioral: Social Cognitive Skills Training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01517360
Promise # 0041
No
Stephen R Marder, MD, VA Greater Los Angeles Healthcare System
VA Greater Los Angeles Healthcare System
National Alliance for Research in Schizophrenia and Affective Disorders
Principal Investigator: Stephen R Marder, MD Department of Veterans Affairs, University of California Los Angeles
VA Greater Los Angeles Healthcare System
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP