Bipolar Disorder in Late Life (Evaluation of MRI Hyperintensities and DTI in Bipolar Disorder)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania
研究概览
简要总结
The purpose of this study is to look at certain structural changes in the brain in people with bipolar disorder or those with a history of Bipolar disorder.
详细描述
Individuals with bipolar disorder or those with a history of bipolar disorder may have certain structural changes in their brain. The purpose of this study is to look at those changes, as well as the assessment of risk factors for bipolar disorders, involving both social and psychological aspects of behavior, age, education, marital relations, nutrition, physical activity, etc., compared with persons not having bipolar disorder. These changes in the brain will be measured by Magnetic Resonance Imaging (MRI).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM-IV diagnosis of bipolar Disorder, Manic and mixed episodes.
- •18 years of age and older, male or female, any race.
- •Capacity to give informed consent and follow study procedures.
排除标准
- •History of alcohol/drug dependence
- •Any metal or pacemaker in the body which precludes MRI
- •Dementia or other primary psychiatric disorders including substance abuse/dependence, anxiety disorders, schizophrenia
- •For controls, numbers one through four above as well as any history of depression or the use of antidepressants
研究组 & 干预措施
Manic Subject with DWM Hyperintensities >2
Subjects with acute mania who were treated with naturalistic protocol (starting with valproic acid) who had a BOYKO DWM Hyperintensity rating >2 and a YMRS <15 at week 3.
干预措施: Valproic Acid (Drug)
Manic Subjects with DWM Hyperintensities <3
Subjects with acute mania who were treated with naturalistic protocol (starting with valproic acid)who had a BOYKO DWM Hyperintensity rating <3 and a YMRS <15 at week 3.
干预措施: Valproic Acid (Drug)
结局指标
主要结局
Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania
时间窗: 3 weeks
Subject with acute mania were treated for 3 weeks with STEP-BD protocol using valproic acid as the primary intervention. Subject MRI's were evaluated for the presence of deep white matter hyperintensities (DWM) (\>2 on the the Boyko Classification). Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded \<5 mm, 3 = irregular \>5 mm, 4 = confluent lesions.
Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment
时间窗: 12 months
Subject were evaluated for relapse of their mood disorder and for the presence of DWM Hyperintensities (\>2 on the the Boyko Classification. Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded \<5 mm, 3 = irregular \>5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). Relapse was defined by protocol as either a MADRS scale \>15 or a YMRS scale \>15.
次要结局
- fa ROFC in Subjects Who Received Continuation Treatment(up to 12 months)
- Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment(up to 12 months)
- fa LOFC in Subjects Who Received Continuation Treatment(up to 12 months)