Open-Label Study of Bupropion SR for Major Depression and Depression NOS in Children and Adolescents With Bipolar and Bipolar Spectrum Disorder
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- reduction in depression symptoms assessed by
研究概览
简要总结
This is an 8-week open label study of bupropion SR in the treatment of youth with bipolar depression with adequate mood stabilization. All youth will be closely monitored for treatment emergent manic activation and drug-drug interactions with ongoing antimanic agents.
The main objective of this study is to assess the safety and effectiveness of bupropion SR in the treatment of bipolar depression in children and adolescents.
详细描述
While anti-manic agents can effectively control manic symptoms, bipolar patients frequently continue to struggle with residual depressive symptomatology that can be associated with severe morbidity and suicidality. Because antidepressants can activate manic symptoms in bipolar patients with depression, the treatment of bipolar depression poses unique and challenging therapeutic dilemmas Thus, the identification of appropriate safe and effective treatment strategies for the management of depression in bipolar youth is particularly taxing considering that pediatric mania is predominantly mixed with a strong depressive component. A recent study in our program of bupropion SR in 30 adults with ADHD and Bipolar disorder, treatment with bupropion SR was extremely well tolerated and was not associated with activation of manic symptoms. Because bupropion has not been evaluated in the treatment of bipolar depression in youth, there is a pressing need to evaluate its effectiveness and safety in the context of a treatment protocol aimed at carefully evaluating this issue.
This is an 8-week open label study of bupropion SR in the treatment of youth with bipolar depression with adequate mood stabilization. All youth will be closely monitored for treatment emergent manic activation and drug-drug interactions with ongoing antimanic agents.
The main objective of this study is to assess the safety and effectiveness of bupropion SR in the treatment of bipolar depression in children and adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females age 6 to 17 with a diagnosis of current depression with bipolar disorder based on clinical assessment and confirmed by structured diagnostic interview plus an initial Hamilton rating scale score >17 and a Young Mania Rating Score of <
- •Children will only be allowed to participate in the trial if they have had mood stabilization on a steady dose of medication for at least 2 months. By mood stabilization we mean as determined by principle investigator, evaluator clinician, and as confirmed by KSADS.
- •Subject and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- •Subjects and their legal representative must be considered reliable.
- •Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
- •Subject must be able to participate in mandatory blood draws.
- •Subject must be able to swallow pills.
排除标准
- •Subjects with chronic medical illness, DSM-IV substance dependence within the past month, pregnant or nursing female subjects will be excluded from this study.
- •Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- •Serious, unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrine, neurologic, immunologic, or hematologic disease.
- •History of severe allergies or multiple adverse drug reactions.
- •Non-febrile seizures without a clear and resolved etiology.
- •Leukopenia or history of leukopenia without a clear and resolved etiology.
- •Judged clinically to be at serious suicidal risk.
- •Acute Psychosis
- •Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol.
- •History of intolerance or non-response to bupropion.
- •Treatment with nonreversible monoamine oxidase inhibitor within 2 weeks prior to initiation of study.
- •Current diagnosis of schizophrenia.
- •History of head trauma
- •CNS tumor
- •Diabetic treated with oral hypoglycemics or insulin
- •Current or prior diagnosis of bulimia or anorexia
结局指标
主要结局
reduction in depression symptoms assessed by
时间窗: baseline to 8 weeks
Children's Depression Rating Scale
时间窗: baseline to 8 weeks
Hamilton Depression Rating scale (HAM-D)
时间窗: baseline to 8 weeks
次要结局
未报告次要终点