Assessment and Follow Up Study of Children and Adolescent With Bipolar Disorder
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI
研究概览
简要总结
This is an outpatient program for children and adolescents with bipolar disorders. The naturalistic approach of the program will allow a proper investigation of the disorder, assessment of environmental and biological factors, the conduction of treatment studies, and follow-up of the subjects.
详细描述
Inclusion criteria:
Age 6-17 years old, male and female. Bipolar Disorder I, II, and NOS (subjects presenting episodes of distinct abnormally and persistently elevated, expansive, or irritable mood, accompanied by at least three -or four if the mood is only irritable - Criteria B symptoms and present to a significant degree for at least 24 hours.
Severe Mood Dysregulation (SMD), as defined by Brotman et al. (American Journal of Psychiatry, 2007)
Exclusion criteria:
Presence of a diagnosis of Pervasive Developmental Disorder, Schizophrenia, Drug Use Disorder, and any other counter indications to outpatient treatment (significant suicide or homicide risk)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6-18 years-old;
- •Bipolar Disorder I, II or NOS
- •Severe Mood Dysregulation
排除标准
- •Schizophrenia
- •Pervasive Developmental Disorder
- •Drug use disorder
- •Severe suicidal or homicidal risk, counterindicating outpatient treatment
研究组 & 干预措施
Psychopharmacotherapy
No specific arms; Treatment decision based on available guidelines
干预措施: Psychopharmacotherapy (Drug)
结局指标
主要结局
Changes in manic and depressive symptoms over time using YMRS, CMRS-P, CDRS, and CDI
时间窗: Naturalistic Study - 2-year follow-up
Polymorphisms at candidate genes for Bipolar Disorder and Attention-Deficit/Hyperactivity Disorder
时间窗: Naturalistic 2-year follow-up
次要结局
- Changes in ADHD symptoms according to SNAP-IV(Naturalistic 2-year follow-up)
- Changes in Anxiety symptoms according to the SCARED-C and SCARED-P(Naturalistic 2-year follow-up)
- Changes in family functioning according to the FES-R, individual functioning according to the EEAC and Resilience Scale, environmental factors according to the Stressful Life Events Scale(Naturalistic 2-year follow-up)
- Presence and onset of adverse events secondary to treatment(Naturalistic 2-year follow-up)
- Changes in SMD symptoms according to the Mood Symptom Questionnaire(Naturalistic 2-year follow-up)
- Changes in general functioning according to the CGI and the CGAS(Naturalistic 2-year follow-up)