Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy

Overview

– 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).

Full Title of Study: “Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy A Retrospective Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 8, 2020

Detailed Description

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).

Arms, Groups and Cohorts

  • Exposure 1
    • commonly prescribed tricyclic antidepressants (Imipramine, Amitriptyline, Clomipramine HCL) administered for at least 3 months
  • Exposure 2
    • commonly prescribed Selective Serotonin Re-uptake inhibitors antidepressants ( Fluoxetine, Fluvoxamine, Sertraline, Citalopram, Paroxetine) administered for at least 3 months
  • Non exposure
    • Non-pharmacological treatment (psychotherapy)

Clinical Trial Outcome Measures

Primary Measures

  • Gustatory thresholds
    • Time Frame: 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.

Secondary Measures

  • Taste intensity at supra-threshold
    • Time Frame: during anticipated period of 7months from February 2020 till August 2020
    • – C.M will assess the taste intensity at supra-threshold level on a 9 point vertical labeled scale (extremely strong, very strong, strong, slightly strong, neutral, slightly weak, weak , very weak, extremely weak) in which subjects indicate the intensity perceived when tasting a substance
  • Gustatory dysfunction modulators
    • Time Frame: during anticipated period of 7months from February 2020 till August 2020
    • -C.M will use an assessment questionnaire (appendix) to assess possible modulators for developing gustatory dysfunction including a number of short-term and long-term factors such as body mass, gender, age, local and systemic diseases, excessive alcohol drinking, drug dependence, smoking, state of oral hygiene, consumption of some foods or drugs

Participating in This Clinical Trial

Inclusion Criteria

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

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christine Raouf George Mikhail, Principal Investigator – Cairo University

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