Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Computer games; Behavioral: Neuroadaptive cognitive training

• Registration Number: NCT00694889
• Lead Sponsor: University of California, San Francisco

Brief Summary

The aim of this study is to investigate the efficacy of neuroscience-guided computerized cognitive training exercises on the remediation of cognitive deficits and symptoms associated with recent-onset schizophrenia and to examine the influence of subject characteristics, brain structure and function, and pharmacotherapy on the response to remediation.

Detailed Description

Participation in this study will last approximately 12 months and will involve individuals with recent-onset schizophrenia. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The 8 weeks of treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard commercially available games, with no targeted response.

Participants will repeat baseline assessments after the computer training and Month 6 of follow-up. The EEG and MRI will be repeated only at post training assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants in the control condition will be offered an opportunity to complete an additional 8 weeks of computer training with different modules.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-11
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
• First psychotic episode within the last 3 years
• Good general physical health
• Age between 12-35
• Is fluent and proficient in the English language
• Achieved clinical stability (e.g., outpatient status for at least 3 months before study entry; on stable doses of medication for at least 1 month before study entry
• Minors must have parental/legal guardian consent to participate

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Exclusion Criteria

• Any neurological disorder
• History of psychoactive substance abuse in the past 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Computer games	Participants will use commercially available computer games.
2	Neuroadaptive cognitive training	Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
3	Neuroadaptive cognitive training	Healthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.

Primary Outcome Measures

Name	Time	Method
Cognitive Performance, as measured by a neuropsychological battery	Measured at Baseline, Week 8, and 6 Month Follow-Up

Secondary Outcome Measures

Name	Time	Method
Symptom profile, as measured by clinical interviews	Measured at Baseline, Week 8, and 6 Month Follow-Up

Trial Locations

Locations (2)

University of California, Davis; 🇺🇸 Sacramento, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States