NCT00655239

Brief Summary

This study will evaluate the effectiveness of intensive computerized cognitive training in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable 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

First Submitted

Initial submission to the registry

April 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

7.9 years

First QC Date

April 7, 2008

Last Update Submit

January 4, 2019

Conditions

Schizophrenia

Keywords

Ultra High Risk of SchizophreniaProdromePsychosisSchizophreniaCognitive Remediation

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance, as measured by a neuropsychological battery

    Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up

Secondary Outcomes (1)

  • Symptom profile, as measured by clinical interviews

    Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up

Study Arms (3)

Control

ACTIVE COMPARATOR

Participants will use commercially available computer games.

Behavioral: Computer games

Active

EXPERIMENTAL

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

Behavioral: Neuroadaptive cognitive training

Healthy Control

ACTIVE COMPARATOR

Healthy participants will receive targeted neuroadaptive cognitive training with neuroplasticity-based software created by Posit Science Corporation.

Behavioral: Neuroadaptive cognitive training

Interventions

Neuroadaptive cognitive trainingBEHAVIORAL

Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.

ActiveHealthy Control
Computer gamesBEHAVIORAL

The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 8 weeks.

Control

Eligibility Criteria

Age12 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meets criteria from the Structured Interview of Prodromal Syndromes for the diagnosis of a prodromal syndrome
  • Good general physical health
  • English is first language
  • Clinically stable (e.g., outpatient status for at least 8 weeks before study entry;on stable doses of medications for at least 1 month before study entry)

You may not qualify if:

  • Confirmed neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94591, United States

Location

Related Publications (1)

  • Loewy R, Fisher M, Schlosser DA, Biagianti B, Stuart B, Mathalon DH, Vinogradov S. Intensive Auditory Cognitive Training Improves Verbal Memory in Adolescents and Young Adults at Clinical High Risk for Psychosis. Schizophr Bull. 2016 Jul;42 Suppl 1(Suppl 1):S118-26. doi: 10.1093/schbul/sbw009. Epub 2016 Feb 22.

    PMID: 26903238DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Sophia Vinogradov, MD

    University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute

    PRINCIPAL INVESTIGATOR

  • Rachel Loewy, PhD

    University of California, San Francisco

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 9, 2008

Study Start

June 1, 2008

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

US(1)