Depressive SymptomsENOLFEANCT03605524
Olfactory Training and Emotional State
A study testing Sensory training in people with Depressive Symptoms and Depressive Disorder, Major, run by University Hospital, Tours at 3 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Depressive Disorder, Major
- What is being tested?
- Sensory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Aug 2018to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
University health service, University ,Tours
Tours, 37000
UMR 1253 IBrain, University, Tours
Tours, 37032
University Psychiatric Clinic, University hospital,Tours
Tours, 37044
About this study
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.
Read the 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.
- Conditions
- Depressive Symptoms, Depressive Disorder, Major
- Being tested
- Sensory training
- Keywords
- Sensory training, Depression, Olfaction, Emotion, Perception
- Medical subject headings
- Depression, Depressive Disorder, Major, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory trainingOther
Also called Olfactory or visual training
12 weeks sensory training
| Study group | Role | What they receive |
|---|---|---|
| Sensory training | Other | 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. Receives: Other: Sensory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Olfactory Perception at 3 months
Score obtained with the Sniffin 'Stick test
Measured: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Secondary outcomes (7)
Emotional perception measured Sense'n Feel Method
Score obtained with Sense'n Feel Method
Measured: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Emotional perception measured with SMI RED-m Scientific device
Observation of spontaneous pupillary dilatation with SMI RED-m Scientific device
Measured: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Psychometric scale MINI : Psychiatric disorders exploration
Mini International Neuropsychiatric Interview
Measured: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Psychometric scale TAS-20 : alexithymia assessment
Twenty-item toronto Alexithymia Scale (TAS-20)
Measured: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Psychometric scale STAI-Y : anxiety assessment
State Trait Anxiety Inventory
Measured: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Psychometric scale SHAPS : anhedonia assessment
The Snaith-Hamilton Pleasure Scale
Measured: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Psychometric scale QIDS-SR16 : Depression assessment
Quick Inventory of Depressive Symptomatology
Measured: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start28 Aug 2018
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wissam EL-HAGE, MD-PhD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605524
- Sponsor's protocol ID
- PHAO17-WEH/ENOLFEA
- Other IDs
- 2018-A00653-52, 2018.05.02
- Acronym
- ENOLFEA
- Status last verified
- Dec 2025
- First submitted
- 12 Jul 2018
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Training and Emotional State
- ClinicalTrials.gov ID
- NCT03605524
- Acronym / sponsor ID
- ENOLFEA / PHAO17-WEH/ENOLFEA
- Conditions
- Depressive Symptoms, Depressive Disorder, Major
- Keywords
- Sensory training, Depression, Olfaction, Emotion, Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sensory training | Other | Other: Sensory trainingSensory (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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- With a diagnosis of depressive episode characterized according to the DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory trainingAlso: Olfactory or visual training12 weeks sensory training | Other | Sensory training |
Primary outcome
Change from Baseline Olfactory Perception at 3 months
Time frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Score obtained with the Sniffin 'Stick test
7 secondary outcomes
Emotional perception measured Sense'n Feel Method
Time frame: 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)
Psychometric scale MINI : Psychiatric disorders exploration
Time frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Psychometric scale TAS-20 : alexithymia assessment
Time frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Psychometric scale STAI-Y : anxiety assessment
Time frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Psychometric scale SHAPS : anhedonia assessment
Time frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Psychometric scale QIDS-SR16 : Depression assessment
Time frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wissam EL-HAGE, MD-PhD study director
University Hospital, Tours
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory training in people with Depressive Symptoms and Depressive Disorder, Major, run by University Hospital, Tours at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Olfactory Perception at 3 months (time frame: Baseline (T0), a month and a half (T1.5), 3 months (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.