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临床试验/NCT02360267
NCT02360267已完成不适用

Pediatric Bipolar Registry

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2013年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
334
试验地点
1
主要终点
Course of diagnosis (per MINI kid interview)

研究概览

简要总结

The goal of the Pediatric Bipolar Registry (PBR) is to provide a comprehensive assessment regarding the diagnosis and treatment of pediatric bipolar disorder to children and adolescents with any current mood state and/or children/adolescents who are offspring of a parent with bipolar disorder (BD) type I or II and their families.

详细描述

Data collected will be utilized to perform a retrospective chart review to include measure outcomes and de-identified demographic information detailed in the attached case report forms. In each case where a diagnosis of bipolar disorder I, bipolar disorder II, or bipolar disorder NOS is determined, the child/adolescent will be added to the PBR and provided with information about local providers that are qualified to treat their diagnosis. Each subject can elect to be notified about future research studies s/he may qualify for. Furthermore, the investigators will provide ongoing newsletters with useful information that addresses the latest research underway in the field with the families. If requested, the investigators will provide a written report to their current provider detailing our evaluation. The potential for a breach in confidentiality always exists; however, information that is obtained will be stored in password a protected database and locked file drawers in locked offices; data will have identifying information sheered from it to prevent loss of confidentiality, and all staff must sign confidentiality certificates. If child abuse is detected, the research team is obligated to follow mandatory state reporting laws. To the investigators' knowledge, there is no registry for Pediatric Bipolar Disorder in the city of Houston or the state of Texas that provides the comprehensive evaluation that we are proposing for these children and adolescents and their families. Therefore, this will be a novel service within this division that will provide research to families and potential clients for providers managing these families across the State of Texas.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Other

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Course of diagnosis (per MINI kid interview)

时间窗: 1 year

AIM I: The goal of the Pediatric Bipolar Registry (PBR) is to provide a comprehensive assessment regarding the diagnosis of pediatric bipolar disorder to children and adolescents with any current mood state and/or children/adolescents who are offspring of a parent with bipolar disorder (BD) type I or II. Data collected will be utilized to perform a retrospective chart review to include measure outcomes and de-identified demographic information detailed in the attached case report forms. Each of these steps will allow result in a comprehensive Pediatric Bipolar Registry database.

次要结局

  • Changes in Young Mania Rating Scale (YMRS) and Childhood Depression Rating Scale (CDRS) scores(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jair Soares

Professor, Principal Investigator

The University of Texas Health Science Center, Houston

研究点 (1)

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