- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03605524
Olfactory Training and Emotional State (ENOLFEA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Tours, France, 37000
- University health service, University ,Tours
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Tours, France, 37032
- UMR 1253 IBrain, University, Tours
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Tours, France, 37044
- University Psychiatric Clinic, University hospital,Tours
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Sensory training
Sensory (Olfactory or visual) training will be done at home for 12 weeks. The effect of the training will be evaluated using an experimental protocol includes (i) clinical and psychometric evaluations, (ii) the study of olfactory perception using Sniffin' Sticks Test and (iii) the study of the emotional perception using the "subjective" Sense'n Feel method and the "objective" measurement of the spontaneous pupillary dilatation. |
12 weeks sensory training
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Olfactory Perception at 3 months
Time Frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
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Score obtained with the Sniffin 'Stick test
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Baseline (T0), a month and a half (T1.5), 3 months (T3)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional perception measured Sense'n Feel Method
Time Frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
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Score obtained with Sense'n Feel Method
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Baseline (T0), a month and a half (T1.5), 3 months (T3)
|
|
Emotional perception measured with SMI RED-m Scientific device
Time Frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
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Observation of spontaneous pupillary dilatation with SMI RED-m Scientific device
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Baseline (T0), a month and a half (T1.5), 3 months (T3)
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Psychometric scale MINI : Psychiatric disorders exploration
Time Frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
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Mini International Neuropsychiatric Interview
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Baseline (T0), a month and a half (T1.5), 3 months (T3)
|
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Psychometric scale TAS-20 : alexithymia assessment
Time Frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
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Twenty-item toronto Alexithymia Scale (TAS-20)
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Baseline (T0), a month and a half (T1.5), 3 months (T3)
|
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Psychometric scale STAI-Y : anxiety assessment
Time Frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
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State Trait Anxiety Inventory
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Baseline (T0), a month and a half (T1.5), 3 months (T3)
|
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Psychometric scale SHAPS : anhedonia assessment
Time Frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
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The Snaith-Hamilton Pleasure Scale
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Baseline (T0), a month and a half (T1.5), 3 months (T3)
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Psychometric scale QIDS-SR16 : Depression assessment
Time Frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
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Quick Inventory of Depressive Symptomatology
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Baseline (T0), a month and a half (T1.5), 3 months (T3)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wissam EL-HAGE, MD-PhD, University Hospital, Tours
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Mood Disorders
- Sensation Disorders
- Depressive Disorder
- Olfaction Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Anosmia
- Depression
- Depressive Disorder, Major
- Musculoskeletal and Neural Physiological Phenomena
- Nervous System Physiological Phenomena
- Sensation
- Smell
Other Study ID Numbers
- PHAO17-WEH/ENOLFEA
- 2018-A00653-52 (Other Identifier: IdRCB)
- 2018.05.02 (Other Identifier: CPP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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