Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 532 for:    Taste Disorders

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03599011
Recruitment Status : Not yet recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Christine Raouf George Mikhail, Cairo University

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).

Condition or disease
Taste Disorders

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).


Layout table for study information
Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy A Retrospective Cohort Study
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. Gustatory thresholds [ Time Frame: during anticipated period of 6 months from January 2019 till June 2019 ]
    - 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.


Secondary Outcome Measures :
  1. Taste intensity at supra-threshold [ Time Frame: during anticipated period of 6 months from January 2019 till June 2019 ]
    - 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

  2. Gustatory dysfunction modulators [ Time Frame: during anticipated period of 6 months from January 2019 till June 2019 ]
    -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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Layout table for additonal information
Responsible Party: Christine Raouf George Mikhail, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03599011     History of Changes
Other Study ID Numbers: CEBD-CU-2018-07-21
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Taste Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antidepressive Agents
Psychotropic Drugs