NCT03605524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

August 28, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

4.8 years

First QC Date

July 12, 2018

Last Update Submit

December 23, 2025

Conditions

Keywords

Sensory trainingDepressionOlfactionEmotionPerception

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Emotional perception measured Sense'n Feel Method

    Baseline (T0), a month and a half (T1.5), 3 months (T3)

  • Emotional perception measured with SMI RED-m Scientific device

    Baseline (T0), a month and a half (T1.5), 3 months (T3)

  • Psychometric scale MINI : Psychiatric disorders exploration

    Baseline (T0), a month and a half (T1.5), 3 months (T3)

  • Psychometric scale TAS-20 : alexithymia assessment

    Baseline (T0), a month and a half (T1.5), 3 months (T3)

  • Psychometric scale STAI-Y : anxiety assessment

    Baseline (T0), a month and a half (T1.5), 3 months (T3)

  • +2 more secondary outcomes

Study Arms (1)

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.

Other: Sensory training

Interventions

12 weeks sensory training

Also known as: Olfactory or visual training
Sensory training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University health service, University ,Tours

Tours, 37000, France

Location

UMR 1253 IBrain, University, Tours

Tours, 37032, France

Location

University Psychiatric Clinic, University hospital,Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorAnosmia

Interventions

Smell

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental DisordersOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wissam EL-HAGE, MD-PhD

    University Hospital, Tours

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 30, 2018

Study Start

August 28, 2018

Primary Completion

June 27, 2023

Study Completion

June 27, 2023

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations