- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00655239
Effectiveness of Neuroadaptive Cognitive Training in Adolescents at Risk for Psychosis
Neuroscience-Guided Cognitive Remediation in Adolescents at Risk for Psychosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Schizophrenia is a severe mental disorder that is marked by significant disruption in a person's thought and emotional processes, frequently involving psychotic features. Identifying behavioral changes and symptoms that indicate the beginning stages of schizophrenia is important for early intervention and prevention of a full psychotic episode. These initial symptoms, known as the prodromal symptoms of psychosis, may include odd behaviors, increased social withdrawal, difficulty concentrating, inappropriate emotional responses, suspicion of others, and dramatic sleep and appetite changes. Common treatments for adolescents demonstrating prodromal symptoms include forms of psychotherapy, nutritional training, and low doses of medication. As a form of psychotherapy, neuroadaptive cognitive training exercises delivered on a computer may be the most effective means of remediating the thinking difficulties of adolescents who are experiencing prodromal symptoms and are at risk for developing a first psychotic episode. This study will evaluate the effectiveness of intensive computerized neuroadaptive cognitive training exercises in preventing the onset of psychotic disorder and improving adaptive functioning in adolescents at high risk of schizophrenia.
Participation in this study will last 24 months and will involve both healthy participants and participants at high risk of schizophrenia. Healthy participants will only participate for 12 months. 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 at high risk of schizophrenia will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Healthy participants will receive treatment with computerized neuroadaptive cognitive training only. All 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 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 at post treatment and Month 6 of follow-up. The EEG and MRI will be repeated only at the Week 8 assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, healthy controls will be complete, and the at risk participants will continue to be followed up out to 24 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94591
- University of California, San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Confirmed neurological disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Participants will use commercially available computer games.
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The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 8 weeks.
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Experimental: Active
Participants will receive targeted neuroadaptive cognitive training with neuroplasticity-based software created by Posit Science Corporation.
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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.
|
Active Comparator: Healthy Control
Healthy participants will receive targeted neuroadaptive cognitive training with neuroplasticity-based software created by Posit Science Corporation.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cognitive performance, as measured by a neuropsychological battery
Time Frame: Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up
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Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptom profile, as measured by clinical interviews
Time Frame: Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up
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Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sophia Vinogradov, MD, University of California, San Francisco; San Francisco VA Medical Center; NCIRE - The Veterans Health Research Institute
- Study Director: Rachel Loewy, PhD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH081051 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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