跳至主要内容
临床试验/jRCT1030230621
jRCT1030230621进行中(未招募)不适用

Prevalence of Generalized Anxiety Disorder in Psychiatric Outpatients: A Multi-center Cross-sectional Study in Japan (PRADO study)

Viatris Pharmaceuticals Japan G.K.0 个研究点目标入组 400 人开始时间: 2024年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
400
主要终点
Prevalence of Generalized Anxiety Disorder

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18age old over 至 80age old not(—)
性别
All

入选标准

  • Patients fulfilling all the following criteria will be enrolled in the study:
  • Patients aged more than or equal to 18 years to less than 80 years at the time of signing the informed consent form.
  • Patients who are outpatients at a psychiatrist department except for the first visit.
  • Patients with a principal diagnosis of ICD-10 Code F30-F39 mood (affective) disorders or F40-F4 neurotic, stress-related, and somatoform disorders.
  • Patients with written consent and are willing to participate in the study

排除标准

  • Ptients will be excluded from the study if any of the following criteria apply:
  • Participants who meet the following based on the applicable ICD-10 category.
  • a. Patients with mental and behavioral disorders due to psychoactive substance use or diagnosed as addictive within 12-months prior to the start of the study.
  • b. Patients with a current or past medical history of schizophrenia, delusional disorder, or other
  • psychotic disorders.
  • c. Patients currently having dementia.
  • d. Patients with mood disorder or anxiety disorder due to known physiological conditions.
  • Patients with a history of convulsive disease other than single febrile seizures in childhood.
  • Patients judged to be at risk of suicide by the investigator.
  • Patients who are considered inappropriate to participate in the study by the investigator

结局指标

主要结局

Prevalence of Generalized Anxiety Disorder

To estimate the prevalence of patients diagnosed with Generalized Anxiety Disorder based on DSM-5 diagnostic criteria, which is confirmed by SCID.

次要结局

  • EQ-5D-5L, QIDS-SR, SDISS, GAD-7, ACE calculator, K6, CGI-S
  • Prevalence of primary diagnosis of Generalized Anxiety Disorder (DSM-5)
  • Prevalence of Generalized Anxiety Disorder (ICD-10)
  • Percentage of psychiatric disorders other than Generalized Anxiety Disorder
  • Percentage of psychiatric disorders comorbid with Generalized Anxiety Disorder
  • Diagnostic agreement with GAD-7 total score
  • Diagnostic agreement with K6 total score
  • Factors associated with Generalized Anxiety Disorder
  • Validity of diagnosis by GAD-7 and K6

研究者

发起方
Viatris Pharmaceuticals Japan G.K.

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