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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03599011
Collaborator
(none)
30
Enrollment
1
Location
7.5
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  • 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).
Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy A Retrospective Cohort Study
    Actual Study Start Date :
    Feb 22, 2020
    Actual Primary Completion Date :
    Aug 8, 2020
    Actual Study Completion Date :
    Oct 7, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. Gustatory thresholds [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 Outcome Measures

    1. Taste intensity at supra-threshold [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

    2. Gustatory dysfunction modulators [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry, Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christine Raouf George Mikhail, Principal Investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03599011
    Other Study ID Numbers:
    • CEBD-CU-2018-07-21
    First Posted:
    Jul 26, 2018
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Taste Disorders

    Study Results

    No Results Posted as of Feb 2, 2021