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Completed

NCT Number: NCT00694889

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of California, Davis, Sacramento, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Neuroadaptive cognitive training

Behavioral

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.

Computer games

Behavioral

The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.

Primary outcomes

  1. Cognitive Performance, as measured by a neuropsychological battery

    Time frame: Measured at Baseline, Week 8, and 6 Month Follow-Up

Secondary outcomes

  1. Symptom profile, as measured by clinical interviews

    Time frame: Measured at Baseline, Week 8, and 6 Month Follow-Up

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Jun 11, 2008
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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