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

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

- 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).

Study Overview

• Status: Completed
• Conditions: Taste Disorders

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
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gustatory thresholds	- 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.	during anticipated period of 7 months from February 2020 till August 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Taste intensity at supra-threshold	- 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	during anticipated period of 7months from February 2020 till August 2020
Gustatory dysfunction modulators	-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	during anticipated period of 7months from February 2020 till August 2020

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Mikhail C, Elgaaly K, Abd El Latif Abd El Hamid A, Shaker O, Ali S. Gustatory Dysfunction among a Sample of Depressed Egyptian Adults under Antidepressants Therapy: A Retrospective Cohort Study. Int J Dent. 2021 Mar 4;2021:5543840. doi: 10.1155/2021/5543840. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2020
• Primary Completion (Actual): August 8, 2020
• Study Completion (Actual): October 7, 2020

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Taste Disorders
• Other Study ID Numbers: CEBD-CU-2018-07-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No