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Completed

NCT Number: NCT03599011

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

- 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).

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Key information

Conditions

Taste Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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