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临床试验/CTRI/2025/11/098208
CTRI/2025/11/098208尚未招募不适用

Comparative effectiveness of Vortioxetine and Paroxetine in peri menopausal and post menopausal depression

Governement Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年12月10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
66
试验地点
1
主要终点
To assess and compare the clinical effectiveness of Vortioxetine and Paroxetine in treatment of perimenopausal and postmenopausal depression

研究概览

简要总结

After obtaining ethical and CTRI approval, 66 women diagnosed with depressive disorders as per ICD 11 and identified as perimenopausal or postmenopausal will be recruited from the Psychiatry and Obstetrics and Gynaecology outpatient departments of GMCH 32 Chandigarh. Participants meeting inclusion criteria and providing written informed consent will be randomly assigned to two groups using a computer generated random number table: Group A Vortioxetine and Group B Paroxetine. Baseline assessments will include sociodemographic and clinical profiles, depression (HDRS 17), anxiety (HAM A), quality of life (WHOQOL BREF Hindi), menopausal symptoms (Menopause Rating Scale), and cognitive functioning (MoCA Hindi, DSST, TMT, Digit Span Test), along with physical and laboratory evaluations.Vortioxetine will be initiated at 10 mg per day adjustable 5 to 20 mg per day and Paroxetine at 12.5 mg per day adjustable 12.5 to 37.5 mg per day based on response on HDRS 17. Patients will be followed up at 2, 4, 6, and 10 weeks to assess clinical improvement, cognitive function, and side effects. Final evaluations, including laboratory and neurocognitive assessments, will be conducted at 10 weeks. A reduction of 50 percent or more in HDRS 17 score from baseline will define treatment response. Participants developing intolerable side effects, becoming UPT positive, or withdrawing consent will be dropped and managed as per protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
45.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Peri menopausal and post menopausal female with diagnosis of depressive disorders as per ICD 11.

排除标准

  • 1.Co-morbid psychiatric conditions such as Schizophrenia, Bipolar Disorder, Obsessive-Compulsive Disorder (OCD), severe depression with psychotic feature, comorbid substance dependence, excluding nicotine and caffeine or exhibiting active suicidal ideation or behaviour.
  • 2.Chronic neurological illnesses or unstable medical conditions.
  • 3.Intellectual Disability.
  • 4.Those who have undergone Cognitive Behavioural Therapy, Cognitive Enhancement Therapy, or electroconvulsive therapy (ECT) within the last three months.
  • Pregnant or breastfeeding women or received hormonal replacement therapy (HRT) within 3 months prior to study enrolment.
  • Known allergy or hypersensitivity reaction to study drugs.
  • 7.Premature menopause (before age of 40 year.

结局指标

主要结局

To assess and compare the clinical effectiveness of Vortioxetine and Paroxetine in treatment of perimenopausal and postmenopausal depression

时间窗: Baseline,2 weeks, 4 weeks, 6 weeks,10 weeks

次要结局

  • •To assess & compare the effectiveness of Vortioxetine & Paroxetine on vasomotor & cognitive symptoms in perimenopausal & postmenopausal women with depression.(•To evaluate tolerability & side effect profile of Vortioxetine & Paroxetine in this demographic.)

研究者

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

Dr RITU

GOVERNMENT MEDICAL COLLEGE AND HOSPITAL, SECTOR 32, CHANDIGARH

研究点 (1)

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