Pharmacological Approach to Improve the Outcome of Social Cognition Training

VA Greater Los Angeles Healthcare System

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Other: Placebo; Drug: Oxytocin; Behavioral: Social Cognitive Skills Training

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT01517360

Promise # 0041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups

Placebo+Social Cognitive Skills Training

Active Comparator group

Description:

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).

Treatment:

Behavioral: Social Cognitive Skills Training

Other: Placebo

Oxytocin+Social Cognitive Skill Training

Experimental group

Description:

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).

Treatment:

Behavioral: Social Cognitive Skills Training

Drug: Oxytocin