Recruiting
Phase 1

Retrain Your Brain

Sponsor:

Bradley Hospital

Code:

NCT01954680

Conditions

Bipolar Disorder

Pediatric Bipolar Disorder

Childhood-onset Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

COGFLEX-skill building levels

COGFLEX-control condition

Study Details

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.

Conditions

Bipolar Disorder

Pediatric Bipolar Disorder

Childhood-onset Bipolar Disorder

Study ID

NCT01954680

Start date

Aug, 2013

Status verified date

Jan, 2018

Completion date

Sep, 2018

Anticipated

Primary completion date

Sep, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: COGFLEX-skill building levels

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.

experimental: COGFLEX-control condition

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.

Interventions

COGFLEX-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.

COGFLEX-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.

Primary outcome measure

  • Change in functional magnetic resonance imaging (fMRI) brain activation [ Time Frame: Change from week 1 to week 8 ]

Central Contacts and Locations

Locations

Bradley Hospital

Recruiting

East Providence, Rhode Island, United States, 02915

Contacts

PediMIND Program

401-432-1600pedimind@gmail.com

Principal Investigator:

Daniel Dickstein, M.D.

More Information

Sponsor

Bradley Hospital

Last update posted

Jan 18, 2018

Last verified

Jan, 2018

Keywords

  • bipolar disorder
  • child
  • adolescent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bradley Hospital on 2018-01-18.