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Effectiveness of Neuroadaptive Cognitive Training in Adolescents at Risk for Psychosis
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), September 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00655239
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Behavioral: Neuroadaptive cognitive training
Behavioral: Computer games
Phase I
Phase II

MedlinePlus related topics: Psychotic Disorders Schizophrenia
Drug Information available for: Amphetamine Methamphetamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Neuroscience-Guided Cognitive Remediation in Adolescents at Risk for Psychosis

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Cognitive performance, as measured by a neuropsychological battery [ Time Frame: Measured at baseline, Weeks 8 and 16, and Month 6 follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom profile, as measured by clinical interviews [ Time Frame: Measured at baseline, Weeks 8 and 16, and Month 6 follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Participants will use commercially available computer games.
Behavioral: Computer games
The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.
2: Experimental
Participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
Behavioral: Neuroadaptive cognitive training
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 16 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuospatial targets. The first 8 weeks of treatment will focus on TCT and the second 8 weeks will focus on visuospatial training.
3: Active Comparator
Healthy participants will receive targeted cognitive training with neuroplasticity-based software created by Posit Science Corporation.
Behavioral: Neuroadaptive cognitive training
Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 16 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal and visuospatial targets. The first 8 weeks of treatment will focus on TCT and the second 8 weeks will focus on visuospatial training.

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 6 months and will involve both healthy participants and participants at high risk of 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 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 16 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 first 8 weeks of treatment will focus on targeted cognitive training (TCT) and the second 8 weeks will focus on visuospatial training. Participants assigned to practice computer games will play standard, commercially available games, with no targeted response.

Participants will repeat baseline assessments at Weeks 8 and 16 of treatment and Month 6 of follow-up. The EEG and MRI will be repeated only at the Week 16 assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants will be offered an opportunity to complete an additional 8 to 16 weeks of computer training with different modules.

  Eligibility

Ages Eligible for Study:   16 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655239

Contacts
Contact: Linda May, PhD, MFT 415-476-7278 lmay@lppi.ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94591
Contact: Linda May, PhD, MFT     415-476-7278     lmay@lppi.ucsf.edu    
Contact: Rachel Loewy, PhD     415-476-7659     rloewy@lppi.ucsf.edu    
Principal Investigator: Rachel Loewy, PhD            
University of California, Davis Recruiting
Davis, California, United States, 95817
Contact: Keur Moua, BA     916-734-0512     keur.moua@ucdmc.ucdavis.edu    
Principal Investigator: Cameron Carter, MD            
Sponsors and 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
Study Director: Cameron Carter, MD University of California, Davis
  More Information

Responsible Party: University of California, San Francisco ( Sophia Vinogradov, MD, Professor of Psychiatry )
Study ID Numbers: R01 MH081051, DDTR B2-NDS
Study First Received: April 7, 2008
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00655239  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Ultra High Risk of Schizophrenia
Prodrome
Psychosis
Schizophrenia
Cognitive Remediation

Study placed in the following topic categories:
Schizophrenia
Methamphetamine
Mental Disorders
Amphetamine
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 30, 2009