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Effectiveness of Neuroadaptive Cognitive Training in Adolescents at Risk for Psychosis

This study is currently recruiting participants.
Study NCT00655239.   Last updated on September 19, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of Neuroadaptive Cognitive Training in Adolescents at Risk for Psychosis
Official Title  Neuroscience-Guided Cognitive Remediation in Adolescents at Risk for Psychosis
Brief 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.

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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  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 Measure  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 ]
Condition  Schizophrenia
Intervention  Behavioral: Neuroadaptive cognitive training
Behavioral: Computer games
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  100
Start Date  June 2008
Completion Date March 2013
Eligibility 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
Gender Both
Ages 16 Years to 25 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Linda May, PhD, MFT     415-476-7278     lmay@lppi.ucsf.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00655239
Organization ID R01 MH081051
Secondary IDs †† DDTR B2-NDS
Study Sponsor  National Institute of Mental Health (NIMH)
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    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date September 2008
First Received Date  April 7, 2008
Last Updated Date September 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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