Clinical trial NCT03605524: Olfactory Training and Emotional State
Official title: Olfactory Training and Emotional State
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Depressive Disorder, Major
Keywords: Sensory training
Depression
Olfaction
Emotion
Perception
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Olfactory Perception at 3 months
timeFrame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary outcomes:
measure: Emotional perception measured Sense'n Feel Method
timeFrame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
measure: Emotional perception measured with SMI RED-m Scientific device
timeFrame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
measure: Psychometric scale MINI : Psychiatric disorders exploration
timeFrame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
measure: Psychometric scale TAS-20 : alexithymia assessment
timeFrame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
measure: Psychometric scale STAI-Y : anxiety assessment
timeFrame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
measure: Psychometric scale SHAPS : anhedonia assessment
timeFrame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
measure: Psychometric scale QIDS-SR16 : Depression assessment
timeFrame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Other outcomes:
Locations:
city: Tours
country: France
facility: University health service, University ,Tours
city: Tours
country: France
facility: UMR 1253 IBrain, University, Tours
city: Tours
country: France
facility: University Psychiatric Clinic, University hospital,Tours
Study officials:
affiliation: University Hospital, Tours
name: Wissam EL-HAGE, MD-PhD
role: STUDY_DIRECTOR
References: