Overview

This trial is active, not recruiting.

Condition schizophrenia
Treatments neuroadaptive cognitive training, computer games
Phase phase 1/phase 2
Sponsor University of California, San Francisco
Collaborator National Institute of Mental Health (NIMH)
Start date June 2008
End date May 2016
Trial size 100 participants
Trial identifier NCT00655239, R01MH081051

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Participants will use commercially available computer games.
computer games
The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 8 weeks.
(Experimental)
Participants will receive targeted neuroadaptive cognitive training with neuroplasticity-based software created by Posit Science Corporation.
neuroadaptive cognitive training
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 participants will receive targeted neuroadaptive cognitive training with neuroplasticity-based software created by Posit Science Corporation.
neuroadaptive cognitive training
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.

Primary Outcomes

Measure
Cognitive performance, as measured by a neuropsychological battery
time frame: Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up

Secondary Outcomes

Measure
Symptom profile, as measured by clinical interviews
time frame: Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 follow-up

Eligibility Criteria

Male or female participants from 12 years up to 35 years old.

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

Additional Information

Official title Neuroscience-Guided Cognitive Remediation in Adolescents at Risk for Psychosis
Principal investigator Sophia Vinogradov, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.