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临床试验/NCT03599011
NCT03599011已完成不适用

Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy A Retrospective Cohort Study

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Gustatory thresholds

研究概览

简要总结

  • Assess gustatory thresholds among a sample of depressed Egyptian adults (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) using filter paper disc(FPD) method through a scoring system. - Determine the taste intensity at supra-threshold among these patients using a psychophysical method through a scoring system. - Identify possible modulators for developing gustatory dysfunction among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).

详细描述

PECO

  • P Population: depressed Egyptian adults under anti-depressants therapy
  • E1 Exposure 1: commonly prescribed tricyclic antidepressants (Imipramine, Amitriptyline, Clomipramine HCL)
  • E2 Exposure 2: commonly prescribed Selective Serotonin Re-uptake inhibitors antidepressants ( Fluoxetine, Fluvoxamine, Sertraline, Citalopram, Paroxetine)
  • C control (non exposure) : non-pharmacological treatment ( psychotherapy)
  • O Outcome:

Primary 1ry : Assess gustatory thresholds among a sample of depressed Egyptian adults (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) using filter paper disc(FPD) method through a scoring system.

Secondary 2ry: - Determine the taste intensity at supra-threshold among these patients using a psychophysical method through a scoring system. - Identify gustatory dysfunction modulators among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Depressed Egyptian adults under antidepressants therapy for at least 3 months/non-pharmacological treatment( psychotherapy)
  • Age from 20 to 50 years old

排除标准

  • Antipsychotics
  • Hypnotics
  • Anticonvulsants
  • Ages other than the mentioned
  • Olfactory dysfunction
  • Chemosensory dysfunction

结局指标

主要结局

Gustatory thresholds

时间窗: during anticipated period of 7 months from February 2020 till August 2020

- C.M will assess the gustatory thresholds using filter paper disc method in which five concentrations of the substances will be used to test the four tastes: sweet, salty, sour and bitter and the concentrations of each taste shall be scored from disc number 1 (lowest) to number 5 (highest). - If the subject cannot detect the taste at the highest concentration, a score of 6 will be given. - The mean of three measurements for each test will be calculated.

次要结局

  • Taste intensity at supra-threshold(during anticipated period of 7months from February 2020 till August 2020)
  • Gustatory dysfunction modulators(during anticipated period of 7months from February 2020 till August 2020)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Raouf George Mikhail

Principal Investigator

Cairo University

研究点 (1)

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