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临床试验/CTRI/2025/11/097615
CTRI/2025/11/097615尚未招募不适用

Evaluation of Premenstrual Dysphoric Disorder and Premenstrual exacerbation of psychiatric disorders

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年12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
500
试验地点
1
主要终点
To estimate the extent of Premenstrual Dysphoric Disorder (PMDD) in females with mental illness.

研究概览

简要总结

This study aims to evaluate Premenstrual Dysphoric Disorder (PMDD) a severe disabling condition involving physical and psychological symptoms that occur a few days before menstruation and distinguish it from the cyclical worsening of existing psychiatric symptoms during the same time, known as premenstrual exacerbation. This study aims to evaluate Premenstrual Dysphoric Disorder (PMDD) a severe disabling condition involving physical and psychological symptoms that occur a few days before menstruation and distinguish it from the cyclical worsening of existing psychiatric symptoms. The aim is to evaluate Premenstrual Dysphoric Disorder (PMDD) and Premenstrual

exacerbation of psychiatric disorders. The objectives are to estimate the extent of Premenstrual Dysphoric Disorder (PMDD) in females with mental illness, estimate the magnitude of premenstrual exacerbation of existing psychiatric disorders and role as well as correlation of

socio-demographic and clinical factors in both PMDD and Premenstrual exacerbation. The study will be a prospective, observational study conducted over 18 months at GMCH, Chandigarh. A total of 500 females with mental illness will be screened using the Premenstrual Symptom Screening Tool (PSST). Those who screen positive will be followed across two visits at least 3-5 weeks apart over 12 weeks, depending on their menstrual cycle. Based on their

existing diagnosis, participants will be grouped into categories including depressive disorder, anxiety disorder, bipolar disorder, schizophrenia spectrum, obsessive compulsive disorder, substance use disorders, and other disorders. Each follow-up will include assessments using DSM-5 criteria for PMDD, C-PASS, SOFAS, and disorder-specific clinician rated scales. The findings may enhance understanding, diagnosis, and management of PMDD and premenstrual symptom worsening in Indian women with mental illness, ultimately improving their quality of life.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Females diagnosed with psychiatric disorder Has had at least two menstrual cycles in the last 3 months.

排除标准

  • Females with evidence of organic brain syndrome or intellectual disability Females diagnosed with neurodevelopmental disorders and neurodegenerative disorders Pregnant or lactating females Females taking oral contraceptive pills violent/unco-operative females Females with any acute, unstable, medical or surgical illnesses.

结局指标

主要结局

To estimate the extent of Premenstrual Dysphoric Disorder (PMDD) in females with mental illness.

时间窗: 0,3-5 weeks, 7-9 weeks

次要结局

  • To estimate the magnitude of Premenstrual exacerbation of existing psychiatric disorders in females with mental illness.
  • To assess the role and correlation of socio-demographic and clinical factors in PMDD and premenstrual exacerbation of existing psychiatric disorders.

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

Dr Ganya Behl

Government Medical College and Hospital, Sector 32, Chandigarh

研究点 (1)

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