NCT02337439

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

3.4 years

First QC Date

January 8, 2015

Last Update Submit

November 3, 2017

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Cognitive test performance

    Neuropsychological testing

    up to 6 months

Secondary Outcomes (2)

  • Psychiatric symptoms

    up to 6 months

  • Social Functioning

    up to 6 months

Study Arms (2)

Sensory Information Processing Training

EXPERIMENTAL

Computerized training designed to improve sensory processing

Behavioral: Sensory Information Processing Training

Active Control Training

ACTIVE COMPARATOR

Commercially available computer exercises that were not designed specifically to improve sensory information processing.

Behavioral: Active Control Training

Interventions

Sensory Information Processing TrainingBEHAVIORAL

Computer exercises requiring identification of visual stimuli on computer screen and response with keyboard

Sensory Information Processing Training
Active Control TrainingBEHAVIORAL

Commercially available educational software

Active Control Training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • schizophrenia or schizoaffective disorder
  • English speaking and reading

You may not qualify if:

  • current substance abuse
  • visual impairment
  • neurological conditions
  • current enrollment in another research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

Related Publications (6)

  • 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.

    PMID: 18514488BACKGROUND

  • Green MF. What are the functional consequences of neurocognitive deficits in schizophrenia? Am J Psychiatry. 1996 Mar;153(3):321-30. doi: 10.1176/ajp.153.3.321.

    PMID: 8610818BACKGROUND

  • 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.

    PMID: 18451009BACKGROUND

  • 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. doi: 10.1176/appi.ajp.2007.07060906.

    PMID: 18056233BACKGROUND

  • 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.

    PMID: 21406461BACKGROUND

  • 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. No abstract available.

    PMID: 23043873BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

August 1, 2014

Primary Completion

January 1, 2018

Study Completion

December 1, 2018

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations

US(1)