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临床试验/CTRI/2024/05/068219
CTRI/2024/05/068219尚未招募不适用

Prevalence of depressive and anxiety symptoms in patients of alcohol versus opioid dependence

Government Medical College and Hospital Chandigarh1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
288
试验地点
1
主要终点
Prevalence of depressive and anxiety symptoms in patients of alcohol versus opioid dependence

研究概览

简要总结

Patients fulfilling the criteria for Alcohol Dependence or Opioid Dependence diagnosed as per ICD-11 will be approached for participation in the study. Two hundred and eighty-eight (288) patients meeting the inclusion and exclusion criteria will be enrolled in the study after obtaining informed written consent. The socio demographic and clinical details shall be recorded on the semi-structured proforma prepared for the study. One hundred and forty-four (144) patients diagnosed as alcohol dependence as per ICD-11 shall be subjected to clinical scales namely Severity of Alcohol Dependence Questionnaire (SADQ-C), Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Rating Scale (HAM-A). One hundred and forty-four (144) patients diagnosed as opioid dependence as per ICD-11 shall be subjected to clinical scales namely Severity of Opiate Dependence Questionnaire (SODQ), Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Rating Scale (HAM-A). After assessment of these symptoms, the same will be communicated to the treating psychiatrist to aid in the subsequent clinical management of the patient. If at any point, any patient withdraws the consent, he/she will be considered dropped out of the study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Male

入选标准

  • Patients fulfilling the criteria for Alcohol Dependence or Opioid Dependence diagnosed as per ICD-11.

排除标准

  • 1.Patients with diagnosis of Organic Brain Syndrome or Intellectual Disability.
  • 2.Patient fulfilling the criteria for both Alcohol Dependence and Opioid Dependence diagnosed as per ICD-
  • 3.Patient in Moderate or Severe Alcohol Withdrawal (CIWA-Ar Score of greater than or equal to 10).
  • 4.Patient in Moderate or Severe Opioid Withdrawal (COWS Score of greater than or equal to 13).
  • 5.Patient in substance intoxication during presentation or interview.
  • 6.Patient of any other substance dependence, other than nicotine or caffeine.
  • 7.Patient on any psychotropic medication for depression or anxiety since last 2 weeks.

结局指标

主要结局

Prevalence of depressive and anxiety symptoms in patients of alcohol versus opioid dependence

时间窗: Baseline

次要结局

  • Assessment & comparison of the severity of depressive & anxiety symptoms with severity of alcohol versus opioid dependence(Baseline)
  • Socio-demographic & clinical correlates of severity of alcohol versus opioid dependence, & comorbid depressive & anxiety symptoms(Baseline)

研究者

发起方
Government Medical College and Hospital Chandigarh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ribhav Gupta

Government Medical College and Hospital, Chandigarh

研究点 (1)

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