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

Bradley Hospital

Status and phase: Unknown; Phase 1

Conditions: Bipolar Disorder; Childhood-onset Bipolar Disorder; Pediatric Bipolar Disorder

Treatments: Behavioral: COGFLEX-skill building levels; Behavioral: COGFLEX-control condition

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01954680

0195-07 COGFLEX

R21MH096850 (U.S. NIH Grant/Contract)

R33MH096850 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

COGFLEX-skill building levels

Experimental group

Description:

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.

Treatment:

Behavioral: COGFLEX-skill building levels

COGFLEX-control condition

Experimental group

Description:

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.

Treatment:

Behavioral: COGFLEX-control condition