NCT01954680|UnknownPhase 1DMC
Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study
COGFLEX
COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder
Loading search results
Sponsor study identifier
Secondary identifiers
NIH
NIH
interventional
40
1 country
1
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 20, 2013
Actual (reported)October 7, 2013
Actual (reported)September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Change in Clinician global Impression Improvement-Irritability
Change from week 1 to week 8
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.
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.
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.
Bradley Hospital
East Providence, Rhode Island, 02915, United States
Daniel Dickstein, M.D.
Bradley Hospital/Alpert Medical School of Brown University
First Submitted
September 20, 2013
First Posted
October 7, 2013
Study Start
August 2013
Date type not reportedTaurine in Adolescents With Bipolar Disorder
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Primary Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 18, 2018
Record last verified: 2018-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: