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COGFLEX-skill building levels for Bipolar Disorder (COGFLEX Trial)

Phase 1
Waitlist Available
Led By Daniel Dickstein, M.D.
Research Sponsored by Bradley Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from week 1 to week 8
Awards & highlights

COGFLEX 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.

Eligible Conditions
  • Bipolar Disorder

COGFLEX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from week 1 to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from week 1 to week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in functional magnetic resonance imaging (fMRI) brain activation
Secondary outcome measures
Irritable Mood

COGFLEX Trial Design

2Treatment groups
Experimental Treatment
Group I: COGFLEX-skill building levelsExperimental Treatment1 Intervention
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.
Group II: COGFLEX-control conditionExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Bradley HospitalLead Sponsor
16 Previous Clinical Trials
1,454 Total Patients Enrolled
1 Trials studying Bipolar Disorder
240 Patients Enrolled for Bipolar Disorder
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,109 Total Patients Enrolled
145 Trials studying Bipolar Disorder
63,545 Patients Enrolled for Bipolar Disorder
Daniel Dickstein, M.D.Principal InvestigatorBradley Hospital/Alpert Medical School of Brown University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study
2013. "Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01954680.
All > Bipolar Disorder
~3 spots leftby Apr 2025
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