NCT01422902

Brief Summary

This study is a multi-site, double-blind, randomized, controlled clinical trial to assess the safety and effectiveness of plasticity-based, adaptive, computerized-based cognitive remediation treatment versus a computer-based control. The investigators proposed that a computerized cognitive remediation program based upon the principles of brain plasticity may improve information processing and thus drive clinically significant improvements in cognitive and functional performance in individuals with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Apr 2012

Typical duration for phase_2 schizophrenia

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

2.9 years

First QC Date

August 22, 2011

Last Update Submit

February 4, 2016

Conditions

Schizophrenia

Keywords

SchizophreniaCognitive deficitsCognitive remediationSoftwareBrain Plasticity

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the effects of plasticity-based, adaptive cognitive remediation on cognitive abilities, functional status and quality of life.

    Each outcome score (MCCB composite score and UPSA-2 total score) will be analyzed separately. The treatment efficacy will be established if and only if both tests on MCCB and UPSA-2 are significant at two-sided alpha level of 0.05.

    6 Months

Secondary Outcomes (1)

  • Demonstration of equivalency in safety effects reported between treatment groups.

    6 Months

Study Arms (2)

Plasticity-based Cognitive Training

EXPERIMENTAL

Computerized plasticity-based adaptive cognitive training, up to 130 hours

Other: Plasticity-based Cognitive Training

Non-plasticity-based Training

ACTIVE COMPARATOR

Commercially available computerized training, up to 130 hours

Other: Non-plasticity-based Training

Interventions

Plasticity-based Cognitive TrainingOTHER
Also known as: brainhq
Plasticity-based Cognitive Training
Non-plasticity-based TrainingOTHER

Computer games

Non-plasticity-based Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of older with confirmed diagnosis of Schizophrenia
  • Adequate decisional and reading capacity
  • Clinical stable
  • Moderate or less severity on Positive and Negative Symptoms Scale
  • English speaker
  • Capable of completing clinical and cognitive assessment battery
  • Lack of visual, auditory or motor capacity to participate in the study
  • Minimal level of extrapyramidal symptoms
  • Minimal level of depressive symptoms

You may not qualify if:

  • Failure to meet suicidality rating criteria
  • Prescribed greater than 2 anti-psychotics
  • Significant alcohol and illicit drug use
  • History of mental retardation or pervasive developmental disorder or other neurological disorder
  • Prior specified computer-based cognitive remediation training
  • Participation in a concurrent study that could affect the outcome of this one

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Palo Alto Veteran's Affairs Medical Center

Palo Alto, California, 94304, United States

Location

Posit Science Corporation

San Francisco, California, 94108, United States

Location

MeSH Terms

Conditions

SchizophreniaCognition Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurocognitive Disorders

Study Officials

  • Henry W. Mahncke, PhD

    Posit Science Corporation

    PRINCIPAL INVESTIGATOR

  • Richard Keefe, PhD

    Schizophrenia Trials Network

    PRINCIPAL INVESTIGATOR

  • Scott Stroup, MD, MPH

    Schizophrenia Trials Network

    PRINCIPAL INVESTIGATOR

  • Cate Stasio

    Posit Science Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 25, 2011

Study Start

April 1, 2012

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

February 8, 2016

Record last verified: 2016-02

Locations

US(2)