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临床试验/CTRI/2024/06/068694
CTRI/2024/06/068694尚未招募不适用

Prevalence, socio-demographic and clinical correlates of polypharmacy in schizophrenia

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2024年7月1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
169
试验地点
1
主要终点
Prevalence, socio-demographic and clinical correlates of polypharmacy in schizophrenia

研究概览

简要总结

A total of 169 patients with a primary diagnosis of schizophrenia according to ICD-10 or ICD- 11 will be approached. The diagnosis of schizophrenia will be reconfirmed as per ICD- 11 by a clinical interview. Those who satisfy the inclusion, exclusion criteria will be enrolled in the study after obtaining written informed consent from the patient/Nominated Representative. The socio-demographic details shall be recorded in the semi-structured proforma prepared for this study and the information about the current psychotropic treatment prescribed will be noted from the OPD treatment card and screened for polypharmacy using the operational definition of ‘being prescribed 2 or more psychotropics for the same clinical condition’ and prolonged psychotropic polypharmacy definition of ‘being prescribed 2 or more psychotropics for a period of 2 or more months’. On the patients who are identified to be on polypharmacy according to the definitions, the severity of current psychopathology will be assessed by applying Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression- severity scale (CGI- S), Global Assessment of Functioning (GAF) scale, Montreal Cognitive Assessment scale- Hindi (H- MoCA), Calgary Depression Scale for Schizophrenia (CDSS) and Young Mania Rating Scale (YMRS). The quality of life will be assessed by applying WHO Quality of Life scale- Brief Hindi (WHO QoL- BREF). The common side effects of the psychotropics will be assessed with the side effect checklist prepared for this study. The reasons for polypharmacy/symptoms experienced by the patient prior to starting each new drug will be asked to the patient and accompanying reliable informant using the checklist of common reasons of polypharmacy and in case the patient or the informant does not know the reasons/ symptom, the patient’s file record will be examined and the reason for polypharmacy that was documented in the follow-ups will be noted. The reasons for polypharmacy will then be further classified into broad types of polypharmacy. The entire procedure will take 70-80 minutes.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with primary diagnosis of schizophrenia as per ICD- 11
  • Patients on follow up for at least 6 months
  • Patients/ Nominated representative willing to give written informed consent
  • Patients accompanied by a reliable informant
  • Patients between 18-65 years of age
  • Any gender.

排除标准

  • Patients already diagnosed with co-morbid psychiatric disorder such as anxiety disorders, depressive disorders, obsessive compulsive disorders, mood disorders and organic disorders.
  • Uncooperative, violent and actively suicidal patients.
  • Persons with co-morbid substance dependence except nicotine and caffeine.
  • Patients with co-morbid Intellectual disability, Alzheimer’s disease, dementia and other neurodegenerative disorders.

结局指标

主要结局

Prevalence, socio-demographic and clinical correlates of polypharmacy in schizophrenia

时间窗: Baseline

次要结局

  • Effect of polypharmacy on psychopathology, quality of life, global functioning, cognitive functions assessed by PANSS, YMRS, CDSS, CGI- S, WHO QOL BREF, GAF, MOCA & the side effects associated with polypharmacy in schizophrenia patients(Baseline)

研究者

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

Vijay Krishna

Government Medical College and Hospital

研究点 (1)

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