Skip to main content
Clinical Trials/NCT03599011
NCT03599011CompletedNot Applicable

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

Cairo University1 site in 1 country30 target enrollmentStarted: February 22, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Gustatory thresholds

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
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

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christine Raouf George Mikhail

Principal Investigator

Cairo University

Study Sites (1)

Loading locations...

Similar Trials