Clinical trial NCT03599011: Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy
Official title: Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Taste Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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).

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:

Primary 1ry : 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.

Secondary 2ry: - Determine the taste intensity at supra-threshold among these patients using a psychophysical method through a scoring system. - Identify gustatory dysfunction modulators among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).

Eligibility criteria: 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

Primary outcomes:
measure: Gustatory thresholds
timeFrame: during anticipated period of 7 months from February 2020 till August 2020
Secondary outcomes:
measure: Taste intensity at supra-threshold
timeFrame: during anticipated period of 7months from February 2020 till August 2020
measure: Gustatory dysfunction modulators
timeFrame: during anticipated period of 7months from February 2020 till August 2020
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
citation: 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.