Olfactory Training and Emotional State

Depressive Symptoms Clinical Trial

— ENOLFEA  

Official title:

Olfactory Training and Emotional State

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
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Symptoms

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)