NCT00312962

Brief Summary

This study will determine the effectiveness of reward-intensive, computer-based targeted cognitive training in improving neurocognitive deficits in people with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

7.9 years

First QC Date

April 7, 2006

Last Update Submit

March 7, 2014

Conditions

Schizophrenia

Keywords

Schizoaffective DisorderCognitive RemediationfMRI

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance as measured by a neuropsychological battery

    Measured at Weeks 8, 14, and 8 and Month 6 follow-up

Secondary Outcomes (2)

  • Symptom profile as measured by clinical interviews

    Measured at Weeks 8, 14, and 8 and Month 6 follow-up

  • Quality of life as measured by clinical interviews

    Measured at Weeks 8, 14, and 8 and Month 6 follow-up

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will use commercially available computer games

Behavioral: Computer games

2

EXPERIMENTAL

Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation

Behavioral: Targeted cognitive training (TCT)

Interventions

Targeted cognitive training (TCT)BEHAVIORAL

TCT includes cognitive remediation exercises that participants practice 1 hour per day, 5 days per week, for 20 weeks. TCT exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuo-spatial targets.

2
Computer gamesBEHAVIORAL

The control treatment involves commercially available computer games that participants practice 1 hour per day, 5 days per week, for 20 weeks.

1

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Good general health
  • First language is English
  • Clinically stable (i.e., no inpatient hospital stays for 3 months prior to study entry; on stable doses of medication)

You may not qualify if:

  • History of substance abuse within 6 months prior to study entry
  • Neurological disorder
  • Any metal in the body, or claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Department of Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (2)

  • Puig O, Fisher M, Loewy R, Miley K, Ramsay IS, Carter CS, Ragland JD, Niendam T, Vinogradov S. Early- Versus Adult-Onset Schizophrenia as a Predictor of Response to Neuroscience-Informed Cognitive Training. J Clin Psychiatry. 2020 Mar 3;81(2):18m12369. doi: 10.4088/JCP.18m12369.

    PMID: 32141724DERIVED

  • Panizzutti R, Hamilton SP, Vinogradov S. Genetic correlate of cognitive training response in schizophrenia. Neuropharmacology. 2013 Jan;64(1):264-7. doi: 10.1016/j.neuropharm.2012.07.048. Epub 2012 Aug 7.

    PMID: 22992330DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Sophia Vinogradov, MD

    UCSF, SFVAMC, NCIRE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2006

First Posted

April 11, 2006

Study Start

April 1, 2004

Primary Completion

March 1, 2012

Study Completion

March 1, 2013

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations

US(1)