Taste Supra-thresholds Among a Sample of Depressed Egyptian Adult Under Anti-depressants Therapy

February 2, 2022 updated by: Christine Raouf George Mikhail, Cairo University

Taste Supra-thresholds Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy A Retrospective Cohort Study

Determine the taste intensity at supra-threshold 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 using a psychophysical method through a scoring system.

Study Overview

Status

Completed

Conditions

Detailed Description

PECO

  • P Population: depressed Egyptian adults under anti-depressants therapy
  • E1 Exposure 1: Tricyclic antidepressants (Imipramine, Amitriptyline, Clomipramine HCL)
  • E2 Exposure 2: Selective Serotonin Re-uptake inhibitors antidepressants ( Fluoxetine, Fluvoxamine, Sertraline, Citalopram, Paroxetine)
  • C control (non exposure) : non-pharmacological treatment ( psychotherapy)
  • O Outcome: Determine the taste intensity at supra-threshold among these patients using a psychophysical method through a scoring system

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 taste intensity at supra-threshold level 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Taste intensity at supra-threshold
Time Frame: during a period of 3 months from February 2021 till April 2021]
- 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 a period of 3 months from February 2021 till April 2021]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Actual)

April 8, 2021

Study Completion (Actual)

May 7, 2021

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)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 18936

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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