- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04923321
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
-
-
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Cairo, Egypt
- Faculty of Dentistry, Cairo University
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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
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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.
Sponsor
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
Additional Relevant MeSH Terms
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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