Bipolar Disorder, Childhood-onset Bipolar Disorder, Pediatric Bipolar Disorder
Conditions
Keywords
bipolar disorder, child, adolescent
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.
Interventions
BEHAVIORALCOGFLEX-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.
BEHAVIORALCOGFLEX-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.
Sponsors
National Institute of Mental Health (NIMH)
Bradley Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Neither participant nor independent evaluator knows group assignment in R33 phase randomized controlled trial.
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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional magnetic resonance imaging (fMRI) brain activation | Change from week 1 to week 8 | We will compare functional magnetic resonance imaging (fMRI) brain activation from week 1 (before intervention starts) to week 8 (after intervention is complete). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician global Impression Improvement-Irritability | Change from week 1 to week 8 | Clinician global Impression Improvement-Irritability |
Countries
United States
Outcome results
None listed