Clinical trial NCT01517360: Pharmacological Approach to Improve the Outcome of Social Cognition Training
Official title: Pharmacological Approach to Improve the Outcome of Social Cognition Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Schizophrenia
Social Cognition
Oxytocin
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
Collaborators: name: National Alliance for Research in Schizophrenia and Affective Disorders
First posted: 2012-01-25
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite Social Cognition Score
timeFrame: Baseline, 6 weeks, and 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: West Los Angeles VA Medical Center
state: California
Study officials:
affiliation: Department of Veterans Affairs, University of California Los Angeles
name: Stephen R Marder, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1176/ajp.153.12.1585.
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.
citation: Heinrichs M, von Dawans B, Domes G. Oxytocin, vasopressin, and human social behavior. Front Neuroendocrinol. 2009 Oct;30(4):548-557. doi: 10.1016/j.yfrne.2009.05.005. Epub 2009 Jun 6.
citation: 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.