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

B

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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