Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study



Status:Recruiting
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:7 - 17
Updated:1/20/2018
Start Date:August 2013
End Date:September 2018

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COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder

The main aim of this study is to test a new, non-medication computer-based potential
treatment for bipolar disorder in children and adolescents.

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.

Prior studies have shown that "computer assisted cognitive remediation"--meaning using
computer "games" to build up a skill that has been shown to be impaired in a specific
disorder--can result in improvement in psychiatric illnesses--including schizophrenia.

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.

Inclusion Criteria:

- 7-17 years old

- bipolar disorder type I preferred (at least 1 week of mania)

Exclusion Criteria:

- no implanted metal (no braces, no cochlear implants)

- can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic
disorder

- no active drug/alcohol abuse/dependence
We found this trial at
1
site
East Providence, Rhode Island 02915
Principal Investigator: Daniel Dickstein, M.D.
Phone: 401-432-1600
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mi
from
East Providence, RI
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