Pharmacological Approach to Improve the Outcome of Social Cognition Training

Schizophrenia Clinical Trial

Official title:

Pharmacological Approach to Improve the Outcome of Social Cognition Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517360
• Other study ID #: Promise # 0041
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2012
• Last updated: March 27, 2013
• Start date: January 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: VA Greater Los Angeles Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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).

Locations

Country	Name	City	State
United States	West Los Angeles VA Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System	National Alliance for Research in Schizophrenia and Affective Disorders

Country where clinical trial is conducted

United States, 

References & Publications (4)

Feifel D, Macdonald K, Nguyen A, Cobb P, Warlan H, Galangue B, Minassian A, Becker O, Cooper J, Perry W, Lefebvre M, Gonzales J, Hadley A. Adjunctive intranasal oxytocin reduces symptoms in schizophrenia patients. Biol Psychiatry. 2010 Oct 1;68(7):678-80. doi: 10.1016/j.biopsych.2010.04.039. Epub 2010 Jul 7. — View Citation

Heinrichs M, von Dawans B, Domes G. Oxytocin, vasopressin, and human social behavior. Front Neuroendocrinol. 2009 Oct;30(4):548-57. doi: 10.1016/j.yfrne.2009.05.005. Epub 2009 Jun 6. Review. — View Citation

Horan WP, Kern RS, Tripp C, Hellemann G, Wynn JK, Bell M, Marder SR, Green MF. Efficacy and specificity of social cognitive skills training for outpatients with psychotic disorders. J Psychiatr Res. 2011 Aug;45(8):1113-22. doi: 10.1016/j.jpsychires.2011.01.015. Epub 2011 Mar 4. — View Citation

Marder SR, Wirshing WC, Mintz J, McKenzie J, Johnston K, Eckman TA, Lebell M, Zimmerman K, Liberman RP. Two-year outcome of social skills training and group psychotherapy for outpatients with schizophrenia. Am J Psychiatry. 1996 Dec;153(12):1585-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Social Cognition Score	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.	Baseline, 6 weeks, and 10 weeks	No