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临床试验/NCT02945423
NCT02945423撤回不适用

Improving the Understanding of Catatonia in Autism

University of Michigan0 个研究点开始时间: 2020年3月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Psychiatric, cognitive and biological identification of catatonia in psychiatric illness

研究概览

简要总结

Catatonia is a neuropsychiatric syndrome which is frequently missed or misdiagnosed among psychiatric patients. The current project is a systematic examination of catatonia which will characterize the phenotype and identify biological correlates that play a central role in the pathophysiology and effective pharmacological treatment of this condition.

详细描述

The specific aims of the study are to:

  1. Identify and phenotype participants ranging in age from 10-30 years old who are already diagnosed with catatonia.
  2. Review laboratory investigations already complete and further conduct any laboratory tests which were not previously completed, to exclude a general medical etiology of catatonia.
  3. Obtain skin biopsy for fibroblast from participant to reprogram somatic cells to iPSC (induced pluripotent cell lines) which will be differentiated to cortical neurons for in vitro pharmacological studies against the target tissue.

Up to 30 patients will be consented. Eligibility will be determined through UM medical record screening. When a potential participant is identified, the study team will reach out to the treating clinician to make contact with participant about research interest. Informed consent will be obtained prior to initiation of any study-related procedures. Consent may be emailed at request of potential participants or their representative in advance of a scheduled research appointment for their review. Additionally, informed consent will take place in person both verbally and in writing, with adequate time for participants to ask questions.

Following informed consent, a comprehensive psychiatric interview will be completed to identify overall psychiatric diagnoses and symptoms of catatonia. Based on this evaluation, a decision will be made whether or not the individual is testable or untestable for neurocognitive assessments.

A physical exam will be performed which will include weight, height, waist and head circumference, as well as vital signs that include blood pressure and pulse rate.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
10 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age range = 10 to 30 years.
  • Already diagnosed with Catatonia during 2005 to
  • Inclusive of current symptoms or have had symptoms in past (symptom

排除标准

  • Onset of catatonia is clearly secondary to general medical condition

结局指标

主要结局

Psychiatric, cognitive and biological identification of catatonia in psychiatric illness

时间窗: Three months

Psychiatric, medical, neuropsychological and biological testing will be completed in approximately 30 subjects and analyzed and reviewed by PI and Co-PIs to determine parameters of catatonia diagnosis in psychiatric patients.

次要结局

未报告次要终点

研究者

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

Neera Ghaziuddin

Associate Professor

University of Michigan

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