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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04923425

Collaborator

(none)

Enrollment

Location

7.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 22, 2020

Actual Primary Completion Date :

Aug 8, 2020

Actual Study Completion Date :

Oct 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

Gustatory dysfunction modulators [during a 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Cairo University	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christine Raouf George Mikhail, Principal Investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT04923425

Other Study ID Numbers:

18936 CairoU

First Posted:

Jun 11, 2021

Last Update Posted:

Jun 16, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Taste Disorders

Study Results

No Results Posted as of Jun 16, 2021