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

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

Identify possible modulators for developing gustatory dysfunction among a sample of depressed Egyptian adults (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) 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: Identify possible 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 possible gustatory dysfunction modulators 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 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 a period of 7months from February 2020 till August 2020

Collaborators and Investigators

• Sponsor: Cairo University

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: June 6, 2021
• First Submitted That Met QC Criteria: June 6, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 13, 2021
• Last Verified: June 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: 18936 CairoU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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