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Behavioral Intervention
Enhanced Cognitive Training Through Exercise for First Schizophrenia Episode (CT&E-RCT Trial)
N/A
Recruiting
Led By Keith Nuechterlein, Ph.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 1 day
Treatment 12 months
Follow Up 3 days
Awards & highlights
Summary
This trial tests if combining brain exercises with physical workouts helps patients after their first schizophrenia episode improve their thinking and daily life skills by boosting brain health.
Eligible Conditions
- Schizophrenia
- Schizophreniform Disorder
- Schizoaffective Disorder
Timeline
Screening ~ 1 day4 visits
Treatment ~ 12 months4 visits
Follow Up ~ 3 days1 visit
Screening ~ 1 day
Treatment ~ 12 months
Follow Up ~3 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brain-derived neurotrophic factor (BDNF)
Global Functioning Scale: mean of Role and Social ratings
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Secondary study objectives
Role Functioning Scale
VO2 Max
YMCA fitness test
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Training & ExerciseExperimental Treatment4 Interventions
This arm involves a combination of systematic computerized cognitive training plus 150 minutes per week of aerobic exercise. All participants will also receive individual case management and supportive psychotherapy as well as Individual Placement and Support.
Group II: Cognitive TrainingActive Control3 Interventions
This arm includes the same systematic computerized cognitive training as the experimental condition, but without the additional aerobic exercise. All participants will also receive individual case management and supportive psychotherapy as well as and Individual Placement and Support.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise
2013
Completed Early Phase 1
~1350
Case management and supportive psychotherapy
2013
N/A
~50
Cognitive Training
2008
Completed Phase 3
~4100
Individual Placement and Support
1999
Completed Phase 4
~500
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,556 Previous Clinical Trials
10,263,713 Total Patients Enrolled
38 Trials studying Schizophrenia
4,767 Patients Enrolled for Schizophrenia
Keith Nuechterlein, Ph.D.Principal Investigator - UCLA Department of Psychiatry & Biobehavioral Sciences
University of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are unable to do physical activities that increase your heart rate and breathing.You have a pre-existing neurological disorder, such as epilepsy, or have had a significant head injury.You have a condition called mental retardation, which means your IQ is less than 70.You have experienced your first episode of a mental illness that causes you to lose touch with reality within the last two years.You have been diagnosed with certain mental illnesses like schizophrenia or schizoaffective disorder.You have a history of alcohol or drug abuse that could have caused or complicated your schizophrenia diagnosis.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Training & Exercise
- Group 2: Cognitive Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Schizophrenia Patient Testimony for trial: Trial Name: NCT02823041 — N/A
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