Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study
NCT ID: NCT01954680
Last Updated: 2018-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2013-08-31
2018-09-30
Brief Summary
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In the study, children and adolescents with bipolar disorder will come to our lab at Bradley Hospital 2-times per week for 8-weeks to "play" a custom computer "game" designed to retrain the brain--to build a skill that my work has shown is impaired in children/adolescents with bipolar disorder.
Before and after this 8-week trial, children will have a special magnetic resonance imaging (MRI) scan.
This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.
If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.
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Detailed Description
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This will be the first National Institute of Mental Health (NIMH)-funded study to use this "retrain your brain" approach in children and adolescents with bipolar disorder.
During this study, we are seeking 40 children and adolescents with bipolar disorder to:
* come to our lab at Bradley Hospital in East Providence R.I. twice per week (each lasting 1 hour) to "play" a special computer game for a total of 8 weeks
* to have a special MRI before and after this 8-week trial to see if our "game" improves brain activity
* it does NOT matter if your child is already on medications--they can continue during this study
* all children/adolescents with bipolar disorder are welcome--as long as they do NOT have implanted metal (no braces, no cochlear implants, etc) because of magnetic resonance imaging (MRI) safety.
This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.
If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
R33 phase enrollment goal of 40 including double-blind placebo-controlled randomized trial of 2 versions of video game potential intervention.
TREATMENT
TRIPLE
Study Groups
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COGFLEX-skill building levels
In the R33, children will be randomized to receive either COGFLEX with skill-building levels or just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks.
COGFLEX-skill building levels
COGFLEX--in English-- is a computer game designed to build up a specific skill that our work has shown is impaired in children and adolescents with bipolar disorder).
In the R33, children will be randomized to receive either COGFLEX with skill-building levels or COGFLEX-control condition which is just baseline/non-probabilistic trials.
All children will play COGFLEX twice per week for 8-weeks.
This same approach has shown great success in many psychiatric disorders including schizophrenia.
This is the first such study in children/adolescents with bipolar disorder.
COGFLEX-control condition
In the R33, children will be randomized to receive either COGFLEX with skill-building levels or the control condition--which is just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks.
COGFLEX-control condition
In the R33, the control condition will be the same COGFLEX "game"--but just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks.
Interventions
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COGFLEX-skill building levels
COGFLEX--in English-- is a computer game designed to build up a specific skill that our work has shown is impaired in children and adolescents with bipolar disorder).
In the R33, children will be randomized to receive either COGFLEX with skill-building levels or COGFLEX-control condition which is just baseline/non-probabilistic trials.
All children will play COGFLEX twice per week for 8-weeks.
This same approach has shown great success in many psychiatric disorders including schizophrenia.
This is the first such study in children/adolescents with bipolar disorder.
COGFLEX-control condition
In the R33, the control condition will be the same COGFLEX "game"--but just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* bipolar disorder type I preferred (at least 1 week of mania)
Exclusion Criteria
* can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic disorder
* no active drug/alcohol abuse/dependence
7 Years
17 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Bradley Hospital
OTHER
Responsible Party
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Principal Investigators
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Daniel Dickstein, M.D.
Role: PRINCIPAL_INVESTIGATOR
Bradley Hospital/Alpert Medical School of Brown University
Locations
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Bradley Hospital
East Providence, Rhode Island, United States
Countries
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Facility Contacts
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Other Identifiers
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