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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
CT&E-RCT Trial Summary
This trial is testing whether a combination of neuroplasticity-based cognitive training and aerobic exercise is more effective than cognitive training alone in improving cognition and function in people with schizophrenia.
Eligible Conditions
- Schizophrenia
- Schizophreniform Disorder
- Schizoaffective Disorder
CT&E-RCT Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Role Functioning Scale
VO2 Max
YMCA fitness test
CT&E-RCT 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
~1310
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
1,528 Previous Clinical Trials
10,276,751 Total Patients Enrolled
38 Trials studying Schizophrenia
4,790 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age requirement for this research project limited to persons under fifty years old?
"According to the eligibility requirements of this medical study, participants must be at least 18 years old and no older than 45."
Answered by AI
Is it feasible to become a participant in this clinical experiment?
"This study requires participants to be aged 18-45 and have a diagnosed illness. Approximately one hundred individuals must take part in this experiment for it to continue."
Answered by AI
Is there still availability for individuals to join this research?
"Clinicaltrials.gov currently lists this clinical trial as actively seeking participants, with the initial post date being September 1st 2016 and the most recent update on August 31st 2022."
Answered by AI
How many test subjects are engaged in this research endeavor?
"Affirmative. Clinicaltrials.gov displays evidence that this clinical trial, originally posted on the 1st of September in 2016, is still recruiting participants. The study seeks to enrol 100 patients at a solitary medical site."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
California
What site did they apply to?
University of California, Los Angeles
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I'm tired of being tired. I don't know who to trust or believe in. I'm scared and hearing voices. People keep calling my name and no one is there.
PatientReceived no prior treatments
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