COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in functional magnetic resonance imaging (fMRI) brain activation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Neither participant nor independent evaluator knows group assignment in R33 phase randomized controlled trial.
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7-17 years old
- •bipolar disorder type I preferred (at least 1 week of mania)
排除标准
- •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
研究组 & 干预措施
COGFLEX-skill building levels
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.
干预措施: COGFLEX-skill building levels (Behavioral)
COGFLEX-control condition
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.
干预措施: COGFLEX-control condition (Behavioral)
结局指标
主要结局
Change in functional magnetic resonance imaging (fMRI) brain activation
时间窗: Change from week 1 to week 8
We will compare functional magnetic resonance imaging (fMRI) brain activation from week 1 (before intervention starts) to week 8 (after intervention is complete).
次要结局
- Change in Clinician global Impression Improvement-Irritability(Change from week 1 to week 8)