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

NCT03599011 | Completed DMC

• 1 other identifier: CEBD-CU-2018-07-21
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

\- Assess gustatory thresholds 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 through a scoring system. - Determine the taste intensity at supra-threshold among these patients using a psychophysical method through a scoring system. - Identify possible modulators for developing gustatory dysfunction among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).

Conditions

Taste Disorders

Outcome Measures

Primary Outcomes (1)

• Gustatory thresholds

  \- C.M will assess the gustatory thresholds using filter paper disc method in which five concentrations of the substances will be used to test the four tastes: sweet, salty, sour and bitter and the concentrations of each taste shall be scored from disc number 1 (lowest) to number 5 (highest). - If the subject cannot detect the taste at the highest concentration, a score of 6 will be given. - The mean of three measurements for each test will be calculated.

  during anticipated period of 7 months from February 2020 till August 2020

Secondary Outcomes (2)

• Taste intensity at supra-threshold

  during anticipated period of 7months from February 2020 till August 2020

• Gustatory dysfunction modulators

  during anticipated 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

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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 gustatory functions 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Related Publications (1)

• Mikhail C, Elgaaly K, Abd El Latif Abd El Hamid A, Shaker O, Ali S. Gustatory Dysfunction among a Sample of Depressed Egyptian Adults under Antidepressants Therapy: A Retrospective Cohort Study. Int J Dent. 2021 Mar 4;2021:5543840. doi: 10.1155/2021/5543840. eCollection 2021.

  PMID: 33747081 DERIVED

MeSH Terms

Conditions

Taste Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological 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: July 16, 2018
• First Posted: July 26, 2018
• Study Start: February 22, 2020
• Primary Completion: August 8, 2020
• Study Completion: October 7, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

EG (1)