NCT04923425

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 6, 2021

Last Update Submit

June 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Depressed Egyptian adults under antidepressants therapy for at least 3 months/non-pharmacological treatment( psychotherapy)
  • Age from 20 to 50 years old

You may not qualify if:

  • Antipsychotics
  • Hypnotics
  • Anticonvulsants
  • Ages other than the mentioned • Olfactory dysfunction
  • Chemosensory dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Taste Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2021

First Posted

June 11, 2021

Study Start

February 22, 2020

Primary Completion

August 8, 2020

Study Completion

October 7, 2020

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations