跳至主要内容
临床试验/CTRI/2024/10/075579
CTRI/2024/10/075579尚未招募不适用

A six months follow up of unipolar depression-recovery and dysfunction in a naturalistic prospective study

Department of Psychiatry1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
65
试验地点
1
主要终点
The correlation between baseline symptom severity, melancholic symptoms, suicidality and functioning in patients with major depressive episode at 1st,3rd and 6th-month follow-up

研究概览

简要总结

The study will evaluate the short-term outcome of major depressive episode in a naturalistic treatment setting.

OBJECTIVES- 1)To assess the severity of depressive symptoms in patients with major depressive episode at 1st,3rd and 6th-month follow-up in a naturalistic treatment setting. 2)To assess melancholic symptoms in patients with Major depressive episode at 1st,3rd and 6th-month follow-up in a naturalistic treatment setting. 3) To assess the correlation between baseline symptom severity, melancholic symptoms, suicidality and functioning in patients with major depressive episode at 1st,3rd and 6th-month follow-up in a naturalistic treatment setting.

The study will be carried out over a period of around 24 months on 65 patients from psychiatry OPD or inpatient ward..Patients with current Diagnosis of Depressive episode (single episode/recurrent) as per ICD-11 and The inventory of depressive symptomatology : Clinician (IDS-C) score of >13, aged 18-60 years, either gender, able to give written informed consent; able to understand English, Hindi or Kannada, on adequate dose of antidepressant treatment will be included except patients non-compliance to medications, not cooperative for comprehensive assessments, receive ECT or ketamine infusion therapy. Primary data will be collected by obtaining first-hand information from the respondents themselves regarding the socio-demographic details based on a semi-structured proforma followed by administration of a series of rating scales over a period of one and half to two hours to evaluate melancholic symptoms, suicidal risk and functioning at baseline.Same patients will be interviewed again in follow up at first(4-6 weeks), third(12-14 weeks) and sixth(24-26 weeks)month during their out-patient visit over a period of 40-50 minutes. During this interview depressive symptoms and functioning will be assessed. Finally the data will be streamlined and statistical analysis will be carried out to assess analyse and correlate the symptoms of the illness and findings of the study using scientific methods.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Any patient with current diagnosis of depressive episode(single episode/recurrent)as per ICD-
  • Those who are on adequate doses of antidepressants therapy.
  • Those coming for follow up at the Department of Psychiatry,Kasturba Hospital.

排除标准

  • Those not able to read English/Hindi/Kannada.
  • Those not willing to consent.

结局指标

主要结局

The correlation between baseline symptom severity, melancholic symptoms, suicidality and functioning in patients with major depressive episode at 1st,3rd and 6th-month follow-up

时间窗: O,4-6 weeks, 12-14 weeks, 24-28 weeks

次要结局

  • The severity of depressive symptoms in patients with major depressive episode at 1st,3rd and 6th-month follow-up in a naturalistic treatment setting.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Titir Surai

Kasturba Medical College,Manipal

研究点 (1)

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