Perceptual Deficits in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Cognitive Remediation for Perceptual Deficits in Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02337439
• Other study ID #: V1CDA2013-24
• Secondary ID: 01856
• Status: Active, not recruiting
• Phase: N/A
• First received: January 8, 2015
• Last updated: November 3, 2017
• Start date: August 2014
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, participants with schizophrenia and schizoaffective are given computer exercises to complete. The goals of the study are to determine whether: 1) any of the computer exercises can improve information processing problems in schizophrenia, 2) improvements in information processing are related to other cognitive improvements, and 3) there are changes in brain activity associated with using the computer exercises.

The study will involve clinical interviews, cognitive tests, and frequent computerized cognitive training over the course of 2 months. Some participants will also have electroencephalography, a non-invasive test that measures brain activity, to determine whether there are changes in brain activity with the computer training.

Description:

Schizophrenia is a disabling neurodevelopmental illness, affecting nearly 1% of the population. The disability of schizophrenia is due in large part to the effects of the illness on cognitive faculties. Current medications for schizophrenia do not generally improve cognition, so a major contribution to disability remains undertreated. Computerized cognitive remediation programs, which produce activity-dependent recruitment of neural resources to specifically enhance under-functioning brain systems, have been effective at improving both cognition and community functioning in patients with schizophrenia, but the effects are still modest. Our preliminary work has suggested that our training is associated with improvements in visual memory, though visual memory has been a cognitive area more refractory to cognitive training.

In this study, participants with schizophrenia or schizoaffective disorder will be randomized to receive different computer exercises to help determine whether computer exercises can improve memory in schizophrenia, and whether the cognitive training is associated with changes in neural activity.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• schizophrenia or schizoaffective disorder

• English speaking and reading

Exclusion Criteria:

• current substance abuse

• visual impairment

• neurological conditions

• current enrollment in another research study

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Sensory Information Processing Training
Computer exercises requiring identification of visual stimuli on computer screen and response with keyboard
• Active Control Training
Commercially available educational software

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System	Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (6)

Carpenter WT, Buchanan RW. Lessons to take home from CATIE. Psychiatr Serv. 2008 May;59(5):523-5. doi: 10.1176/ps.2008.59.5.523. — View Citation

Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. Review. — View Citation

McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. — View Citation

Surti TS, Wexler BE. A pilot and feasibility study of computer-based training for visual processing deficits in schizophrenia. Schizophr Res. 2012 Dec;142(1-3):248-9. doi: 10.1016/j.schres.2012.09.013. Epub 2012 Oct 6. — View Citation

Tandon R, Keshavan MS, Nasrallah HA. Schizophrenia, "just the facts" what we know in 2008. 2. Epidemiology and etiology. Schizophr Res. 2008 Jul;102(1-3):1-18. doi: 10.1016/j.schres.2008.04.011. Epub 2008 Jun 2. Review. — View Citation

Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive test performance	Neuropsychological testing	up to 6 months
Secondary	Psychiatric symptoms	Clinical interviews and ratings	up to 6 months
Secondary	Social Functioning	Clinical rating scales	up to 6 months