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

NCT01954680 | Unknown Phase 1 DMC

• 3 other identifiers: 0195-07 COGFLEXR21MH096850R33MH096850
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

bipolar disorder; child; adolescent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Clinician global Impression Improvement-Irritability

  Change from week 1 to week 8

Study Arms (2)

COGFLEX-skill building levels

EXPERIMENTAL

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.

Behavioral: COGFLEX-skill building levels

COGFLEX-control condition

EXPERIMENTAL

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.

Behavioral: COGFLEX-control condition

Interventions

COGFLEX-skill building levels BEHAVIORAL

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.

Also known as: COGFLEX is a computer assisted cognitive remediation

COGFLEX-skill building levels

COGFLEX-control condition BEHAVIORAL

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.

COGFLEX-control condition

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• bipolar disorder type I preferred (at least 1 week of mania)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bradley Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Bradley Hospital

East Providence, Rhode Island, 02915, United States

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Daniel Dickstein, M.D.

  Bradley Hospital/Alpert Medical School of Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Neither participant nor independent evaluator knows group assignment in R33 phase randomized controlled trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: October 7, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

US (1)