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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03605524
Other study ID # PHAO17-WEH/ENOLFEA
Secondary ID 2018-A00653-5220
Status Recruiting
Phase N/A
First received
Last updated
Start date August 28, 2018
Est. completion date August 2023

Study information

Verified date May 2022
Source University Hospital, Tours
Contact Wissam EL-HAGE, MD-PhD
Phone 02.34.37.96.31
Email el-hage@med.univ-tours.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During the past three decades, researchers have paid particular attention to the study of olfactory disorders in depression. Recent studies have shown that depression is characterized by a change in olfactory and emotional perception resulting in a decrease of the perception of positive stimuli (odors and facial expressions) and an increase in perception of negative stimuli (odors). Moreover, it has also been shown in healthy subjects that the presence of minor depressive symptoms leads to a decreasing of olfactory sensitivity. However, odor discrimination was not impaired in these subjects. This observation suggest the presence of a change in "targeted" olfactory perception in people with depressive symptoms without reporting major depression. In addition, studies in subjects with olfactory disorders (following respiratory tract infections or following Parkinson's disease) have shown an improvement in olfactory function after daily training with odors during 12 weeks. From all these observations, the hypothesis is that an olfactory training could improve the overall olfactory functioning and the emotional perception of the subjects presenting minor depressive symptoms and of the depressed patients.


Description:

Recent studies have shown that depression is characterized by a change in olfactory and emotional perception resulting in a decrease of the perception of positive stimuli (odors and facial expressions) and an increase in perception of negative stimuli (odors). Moreover, it has also been shown in healthy subjects that the presence of minor depressive symptoms leads to a decreasing of olfactory sensitivity. However, odor discrimination was not impaired in these subjects. This observation suggest the presence of a change in "targeted" olfactory perception in people with depressive symptoms without reporting major depression. In addition, studies in subjects with olfactory disorders (following respiratory tract infections or following Parkinson's disease) have shown an improvement in olfactory function after daily training with odors during 12 weeks. Therefore, the hypothesis is that an olfactory training could improve the overall olfactory functioning and the emotional perception of the subjects presenting minor depressive symptoms and of the depressed patients. The main objective is to study the effect of daily olfactory training on the emotional state and emotional perception of the subject. The effect of the training will be evaluated using three types of evaluations: (1) a clinical evaluation and the psychometric scales, (2) the investigation of the olfactory function and (3) the study of the emotional perception. The secondary objectives are: - The identification of olfactory parameters and emotional valences associated with minor depressive symptoms. - The study of the link between the subjective and objective emotional response on the one hand, and the link between olfactory function, emotional perception and emotional state on the other hand in depressed patients and in individuals with minor depressive symptoms.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date August 2023
Est. primary completion date August 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria healthy subjects: - Without psychiatric history - QIDS scale score less than or equal to 15 - Affiliation to a social security system - Able to give his written informed consent Inclusion Criteria depressed patients: - With a diagnosis of depressive episode characterized according to the DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI) - No argument for bipolar disorder or schizophrenia, confirmed by the MINI - QIDS scale score greater than or equal to 16 - Follow-up in hospitalization and / or ambulatory consultation - Without comorbidities (alcoholism, eating disorders ...) - Affiliation to a social security system - Able to give his written informed consent Exclusion Criteria healthy subjects and depressed patients: - Pathology or condition likely to modify their olfactory and / or taste perception - Allergies with one or more odors, food allergies and / or known anosmias and ageusia - Legal incapacity and / or circumstances rendering the person incapable of understanding the nature, objectives or consequences of the study

Study Design


Intervention

Other:
Sensory training
12 weeks sensory training

Locations

Country Name City State
France UMR 1253 IBrain, University, Tours Tours
France University health service, University ,Tours Tours
France University Psychiatric Clinic, University hospital,Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Olfactory Perception at 3 months Score obtained with the Sniffin 'Stick test Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary Emotional perception measured Sense'n Feel Method Score obtained with Sense'n Feel Method Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary Emotional perception measured with SMI RED-m Scientific device Observation of spontaneous pupillary dilatation with SMI RED-m Scientific device Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary Psychometric scale MINI : Psychiatric disorders exploration Mini International Neuropsychiatric Interview Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary Psychometric scale TAS-20 : alexithymia assessment Twenty-item toronto Alexithymia Scale (TAS-20) Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary Psychometric scale STAI-Y : anxiety assessment State Trait Anxiety Inventory Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary Psychometric scale SHAPS : anhedonia assessment The Snaith-Hamilton Pleasure Scale Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary Psychometric scale QIDS-SR16 : Depression assessment Quick Inventory of Depressive Symptomatology Baseline (T0), a month and a half (T1.5), 3 months (T3)
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