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

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01954680
Study type	Interventional
Source	Bradley Hospital
Contact
Status	Recruiting
Phase	Phase 1
Start date	August 2013
Completion date	September 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05111548` - Brain Stimulation and Cognitive Training - Efficacy	N/A
Completed	`NCT02855762` - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder	N/A
Recruiting	`NCT05915013` - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response	Phase 1
Recruiting	`NCT05206747` - Ottawa Sunglasses at Night for Mania Study	N/A
Completed	`NCT02513654` - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects	Phase 1
Recruiting	`NCT06313918` - Exercise Therapy in Mental Disorders-study	N/A
Completed	`NCT02304432` - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine	Early Phase 1
Recruiting	`NCT06197048` - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder	N/A
Completed	`NCT03497663` - VIA Family - Family Based Early Intervention Versus Treatment as Usual	N/A
Completed	`NCT04284813` - Families With Substance Use and Psychosis: A Pilot Study	N/A
Completed	`NCT02212041` - Electronic Cigarettes in Smokers With Mental Illness	N/A
Recruiting	`NCT05030272` - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings	N/A
Recruiting	`NCT04298450` - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention	N/A
Active, not recruiting	`NCT03641300` - Efficacy of Convulsive Therapies for Bipolar Depression	N/A
Not yet recruiting	`NCT04432116` - Time and Virtual Reality in Schizophrenia and Bipolar Disorder	N/A
Terminated	`NCT02909504` - Gao NARASD Lithium Study	Phase 4
Completed	`NCT02970721` - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Terminated	`NCT02893371` - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Recruiting	`NCT02481245` - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study	Phase 2
Recruiting	`NCT03088657` - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms