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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

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

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

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

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
2,821 Previous Clinical Trials
2,693,035 Total Patients Enrolled
146 Trials studying Bipolar Disorder
64,045 Patients Enrolled for Bipolar Disorder
Daniel Dickstein, M.D.Principal InvestigatorBradley Hospital/Alpert Medical School of Brown University
~3 spots leftby Sep 2025
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