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

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ClinicalTrials.gov Identifier: NCT03599011
Recruitment Status : Enrolling by invitation
First Posted : July 26, 2018
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Christine Raouf George Mikhail, Cairo University

Tracking Information
First Submitted Date July 16, 2018
First Posted Date July 26, 2018
Last Update Posted Date September 1, 2020
Actual Study Start Date February 22, 2020
Actual Primary Completion Date August 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 29, 2020)
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.
Original Primary Outcome Measures
 (submitted: July 24, 2018)
Gustatory thresholds [ Time Frame: during anticipated period of 6 months from January 2019 till June 2019 ]
- 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.
Change History
Current Secondary Outcome Measures
 (submitted: August 9, 2020)
  • 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
Original Secondary Outcome Measures
 (submitted: July 24, 2018)
  • Taste intensity at supra-threshold [ Time Frame: during anticipated period of 6 months from January 2019 till June 2019 ]
    - 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 6 months from January 2019 till June 2019 ]
    -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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy
Official Title Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy A Retrospective Cohort Study
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).
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Depressed Egyptian adults under anti-depressants therapy The patients will be recalled using their phone numbers recorded in their follow up records in order to come to the Diagnosis center at the faculty of Dentistry, Cairo University to be assessed for gustatory functions and will be given identification numbers and divided into three groups, to which the operator shall be blinded.
Condition Taste Disorders
Intervention Not Provided
Study Groups/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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Actual Enrollment
 (submitted: August 29, 2020)
30
Original Estimated Enrollment
 (submitted: July 24, 2018)
66
Estimated Study Completion Date September 2020
Actual Primary Completion Date August 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03599011
Other Study ID Numbers CEBD-CU-2018-07-21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Christine Raouf George Mikhail, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
Investigators Not Provided
PRS Account Cairo University
Verification Date August 2020