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

Bipolar Disorder Clinical Trial

— COGFLEX  

Official title:

COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01954680
• Other study ID #: 0195-07 COGFLEX
• Secondary ID: R21MH096850R33MH
• Status: Recruiting
• Phase: Phase 1
• First received: September 20, 2013
• Last updated: January 16, 2018
• Start date: August 2013
• Est. completion date: September 2018

Study information

• Verified date: January 2018
• Source: Bradley Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Childhood-onset Bipolar Disorder
• Disease
• Pediatric Bipolar Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Bradley Hospital	East Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Bradley Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional magnetic resonance imaging (fMRI) brain activation	We will compare functional magnetic resonance imaging (fMRI) brain activation from week 1 (before intervention starts) to week 8 (after intervention is complete).	Change from week 1 to week 8
Secondary	Change in Clinician global Impression Improvement-Irritability	Clinician global Impression Improvement-Irritability	Change from week 1 to week 8

External Links

•   Pediatric Mood Imaging and NeuroDevelopment (PediMIND) Program Website