NCT02591498

Brief Summary

The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for people with schizophrenia in the Brazilian population.

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
100

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_3 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

January 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4.9 years

First QC Date

December 16, 2014

Last Update Submit

January 12, 2018

Conditions

Keywords

cognitive training

Outcome Measures

Primary Outcomes (1)

  • Global cognition score change

    The global cognition score is a composite measure from the MATRICS (Measurement And Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery tests

    through study completion, an average of 1 year

Secondary Outcomes (20)

  • Processing speed score change

    through study completion, an average of 1 year

  • Attention score change

    through study completion, an average of 1 year

  • Working memory score change

    through study completion, an average of 1 year

  • Verbal memory and learning score change

    through study completion, an average of 1 year

  • Visuospatial memory and learning score change

    through study completion, an average of 1 year

  • +15 more secondary outcomes

Study Arms (3)

Auditory

ACTIVE COMPARATOR

Administration of 40 hours of auditory training exercises

Behavioral: Computerized cognitive training

Visual

ACTIVE COMPARATOR

Administration of 40 hours of visual training exercises

Behavioral: Computerized cognitive training

Video Games

PLACEBO COMPARATOR

Administration of 40 hours of commercial video games

Behavioral: Computerized cognitive training

Interventions

AuditoryVideo GamesVisual

Eligibility Criteria

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

You may qualify if:

  • clinical diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV criteria
  • age 18- 60 years
  • Portuguese as primary language (learned before age 12)
  • no major medical or neurological disorder that precludes participation in the study

You may not qualify if:

  • IQ score \<70
  • active substance dependence (DSM-IV criteria)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941590, Brazil

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Rogerio Panizzutti, M.D., Ph.D.

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rogerio Panizzutti, M.D., Ph.D.

CONTACT

Linda Scoriels, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 16, 2014

First Posted

October 29, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations