Clinical trial NCT01954680: Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study
Official title: COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bipolar Disorder
Pediatric Bipolar Disorder
Childhood-onset Bipolar Disorder
Keywords: bipolar disorder
child
adolescent
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: R21 phase was an open phase 1a trial for feasibility and acceptability with enrollment goal including intervention development of 20.

R33 phase enrollment goal of 40 including double-blind placebo-controlled randomized trial of 2 versions of video game potential intervention.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in functional magnetic resonance imaging (fMRI) brain activation
timeFrame: Change from week 1 to week 8
Secondary outcomes:
measure: Change in Clinician global Impression Improvement-Irritability
timeFrame: Change from week 1 to week 8
Other outcomes:
Locations:
city: East Providence
country: United States
facility: Bradley Hospital
state: Rhode Island
Study officials:
affiliation: Bradley Hospital/Alpert Medical School of Brown University
name: Daniel Dickstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References: