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Effectiveness of Neuroadaptive Cognitive Training in Adolescents at Risk for Psychosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00655239
First received: April 7, 2008
Last updated: July 2, 2014
Last verified: July 2014
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Neuroscience-Guided Cognitive Remediation in Adolescents at Risk for Psychosis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Cognitive performance, as measured by a neuropsychological battery [ Time Frame: Measured at baseline, Weeks 8 and Month 6, 12, 18, and 24 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 Month 6, 12, 18, and 24 follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
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 8 weeks.
Experimental: Active
Participants will receive targeted neuroadaptive 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 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.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 35 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: PART Program 415-476-7278

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94591
Contact: PART Program    415-476-7278      
Contact: Rachel Loewy, PhD    415-476-7659    rloewy@lppi.ucsf.edu   
Principal Investigator: Rachel Loewy, PhD         
Sponsors and Collaborators
University of California, San Francisco
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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00655239     History of Changes
Other Study ID Numbers: R01 MH081051, R01MH081051, DDTR B2-NDS
Study First Received: April 7, 2008
Last Updated: July 2, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Ultra High Risk of Schizophrenia
Prodrome
Psychosis
Schizophrenia
Cognitive Remediation

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 24, 2014