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

Completed

• Conditions: Taste Disorders

• Registration Number: NCT03599011
• Lead Sponsor: Cairo University

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 Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Study Start: 2020-02-22
• Primary Completion: 2020-08-08
• Study Completion: 2020-10-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt