Major Depressive DisorderDEPSENSNCT05686668
Evolution of the Sensory Profile in Depression
An observational study of Major Depressive Disorder, run by Centre Hospitalier Esquirol at 1 site in France.
Trial summary
The perception of the environment through the study of sensory awareness is important to understand the adaptive or symptomatological behaviors (e.g., withdrawal, increased activity level, stimulation seeking, etc.). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- assessment by scales
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2022to 10 Jan 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized poeple for a major depressive disorder
Who may be able to join
- Male or female, 18 to 65 years of age
- who have given informed consent
- with a diagnosis of a major depressive disorder according to the DSM-5 criteria
- in full hospitalization for less than 10 days in the care units of the Esquirol Hospital
Who cannot join
- Psychiatric comorbidity (personality disorder, addiction other than tobacco, eating disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia and related disorders)
- Proven sensory or neurological disability
- Inability to understand the questionnaires and information related to the study
- Hospitalization under constraint, pregnancy, subjects under guardianship or curatorship, lack of social protection
Trial locations and contacts
1 site in 1 country.
About this study
The perception of the environment through the study of sensory awareness is important to understand the adaptive or symptomatological behaviors (e.g., withdrawal, increased activity level, stimulation seeking, etc.). Sensory processing disorders, such as hypersensitivities or hyposensitivities, have been described in people with depression using the Adolescent Adult Sensory Profile scale. In a recent study, similar results consistent with extreme sensory profiles (hypersensitivity, hyposensitivity, sensation avoidance) in adults with a major depressive disorder were observed. The evolution over time of the sensory profile in people with a depressive disorder is not known. It is currently unknown whether these extreme sensory processing profiles are stable over time or whether they may evolve with the depressive symptomatology to normalize with clinical improvement.
This knowledge could have an important impact both on the symptomatological expression of the disorder, its recognition, and also on the management of the patient. The investigators aim to study the evolution over time of the sensory profile of depressed subjects hospitalized using the ASSP. The behavioral responses of individuals with sensory processing disorder may be related to the coping strategies of these individuals with their living environment. In a second step, the investigators will study the second step the sensory profile of subjects with depression according to their coping strategies, their living environment and their clinical characteristics (anxiety (anxiety, psychomotor slowing, self-esteem, anhedonia).
Read the detailed description
Main objective To compare the sensory profiles, i.e., the distribution of sensory processing patterns at each quadrant of the AASP, of subjects with major depressive disorder at the beginning of hospitalization (V1), and 3 months later (V2).
Secondary objectives
- Objective 1: To describe at V1 and V2, the sensory profiles according to the clinical characteristics (anxiety, depression, psychomotor slowing, self-esteem, anhedonia); a difference in the relationship between the clinical scales and the quadrants (AASP) at V2 and V1 could be observed.
- Objective 2: To look for a difference in sensory profile at V2 according to clinical improvement
- Objective 3: To compare, at V1, the distribution of processing patterns of sensory profiles for each quadrant of the AASP, according to coping styles (CISS).
- Objective 4: To compare the distribution of processing patterns of sensory profiles sensory profiles for each quadrant of the AASP, according to socio-demographic characteristics: gender, age group, professional category, type of type of housing, environment, family situation
- Objective 5: To look for a difference in the distribution of the processing patterns sensory profiles between the first inclusion visit (V1) and 3 months (V2), according to the type of drug treatment (molecules and classes) and non (psychotherapy, relaxation, rTMS, ECT) Inclusion criteria
- Male or female, 18 to 65 years of age
- who have given informed consent
- with a diagnosis of a major depressive disorder according to the DSM-5 criteria
- in full hospitalization for less than 10 days in the care units of the Esquirol Hospital
Non inclusion criteria
- Psychiatric comorbidity (personality disorder, addiction other than tobacco, eating disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia and related disorders)
- Sensory or neurological disability
- Inability to understand the questionnaires and information related to the study
- Hospitalization under constraint, pregnancy, subjects under guardianship or curatorship, lack of social protection
Outcome Measures Primary endpoints
- AASP at V1 and V2 Secondary endpoints
- AASP, HARS, HAM-D, CORE, EES-10, SHAPS at V1 and V2
- AASP, HAM-D at V2
- AASP, ISSC
- AASP scores and socio-demographic characteristics (age, sex ratio, living environment, family status, housing)
- AASP scores and treatments at V1 and V2
- Conditions
- Major Depressive Disorder
- Being tested
- assessment by scales
- Keywords
- Major Depressive Disorder, Adolescent Adult Sensory Profile, Sensory Profiles, Coping
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment by scalesOther
Assessment from many scales: AASP, HARS, HDRS, CORE, EES, CISS, SHAPS at V1 Assessment from many scales: AASP, HARS, HDRS, CORE, EES, SHAPS at V2
| Study group | Role | What they receive |
|---|---|---|
| AASP | Not described Receives: Other: assessment by scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adolescent Adult Sensory Profile score
measure a change in Adolescent Adult Sensory Profile score between he beginning of hospitalization and 3 months
Measured: day 0 and 3 months
Secondary outcomes (7)
Hamilton Anxiety Rating Scale score
measure a change in Adolescent Adult Sensory Profile score according to the HARS
Measured: day 0 and 3 months
number of participants with psychomotor retardation
measure a change in Adolescent Adult Sensory Profile score according to the psychomotor retardation-CORE scale
Measured: day 0 and 3 months
Snaith-Hamilton pleasure scale score
measure a change in Adolescent Adult Sensory Profile score according to SHAPS score
Measured: day 0 and 3 months
Coping Inventory for Stressful Situations score
the distribution of processing patterns of sensory profiles were compared according to coping styles based on CISS score
Measured: day 0
number of participants living in country
compare the Adolescent Adult Sensory Profile score according to living environment (country or town)
Measured: day 0
number of participants living lonely
compare the Adolescent Adult Sensory Profile score according to the family status (living alone or with people)
Measured: day 0
Treatments
measure a change in Adolescent Adult Sensory Profile score according to the traitments (antidepressant, anxiolytic, neuroleptic, psycho-corporal therapy)
Measured: day 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start10 Jan 2022
- Primary completion10 Jan 2022
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aude Paquet, Centre Hospitalier Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686668
- Sponsor's protocol ID
- CHEsquirol
- Acronym
- DEPSENS
- Status last verified
- Feb 2025
- First submitted
- 15 Dec 2022
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paquet A, Fiegl L, Plansont B, Bessaguet C, Gauthier A, Laplace B. Sensory Processing Profiles in Depression: Evidence of Dynamic Changes and Clinical Correlates Over 3 Months. Depress Anxiety. 2026 Sep 4;2026:8238928. doi: 10.1155/da/8238928. eCollection 2026.
PubMed 42698872
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Sensory Profile in Depression
- ClinicalTrials.gov ID
- NCT05686668
- Acronym / sponsor ID
- DEPSENS / CHEsquirol
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Adolescent Adult Sensory Profile, Sensory Profiles, Coping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 17 Jan 2023 (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.
The perception of the environment through the study of sensory awareness is important to understand the adaptive or symptomatological behaviors (e.g., withdrawal, increased activity level, stimulation seeking, etc.). Sensory processing disorders, such as hypersensitivities or hyposensitivities, have been described in people with depression using the Adolescent Adult Sensory Profile scale. In a recent study, similar results consistent with extreme sensory profiles (hypersensitivity, hyposensitivity, sensation avoidance) in adults with a major depressive disorder were observed. The evolution over time of the sensory profile in people with a depressive disorder is not known. It is currently unknown whether these extreme sensory processing profiles are stable over time or whether they may evolve with the depressive symptomatology to normalize with clinical improvement.
This knowledge could have an important impact both on the symptomatological expression of the disorder, its recognition, and also on the management of the patient. The investigators aim to study the evolution over time of the sensory profile of depressed subjects hospitalized using the ASSP. The behavioral responses of individuals with sensory processing disorder may be related to the coping strategies of these individuals with their living environment. In a second step, the investigators will study the second step the sensory profile of subjects with depression according to their coping strategies, their living environment and their clinical characteristics (anxiety (anxiety, psychomotor slowing, self-esteem, anhedonia).
Detailed description
Main objective To compare the sensory profiles, i.e., the distribution of sensory processing patterns at each quadrant of the AASP, of subjects with major depressive disorder at the beginning of hospitalization (V1), and 3 months later (V2).
Secondary objectives
- Objective 1: To describe at V1 and V2, the sensory profiles according to the clinical characteristics (anxiety, depression, psychomotor slowing, self-esteem, anhedonia); a difference in the relationship between the clinical scales and the quadrants (AASP) at V2 and V1 could be observed.
- Objective 2: To look for a difference in sensory profile at V2 according to clinical improvement
- Objective 3: To compare, at V1, the distribution of processing patterns of sensory profiles for each quadrant of the AASP, according to coping styles (CISS).
- Objective 4: To compare the distribution of processing patterns of sensory profiles sensory profiles for each quadrant of the AASP, according to socio-demographic characteristics: gender, age group, professional category, type of type of housing, environment, family situation
- Objective 5: To look for a difference in the distribution of the processing patterns sensory profiles between the first inclusion visit (V1) and 3 months (V2), according to the type of drug treatment (molecules and classes) and non (psychotherapy, relaxation, rTMS, ECT) Inclusion criteria
- Male or female, 18 to 65 years of age
- who have given informed consent
- with a diagnosis of a major depressive disorder according to the DSM-5 criteria
- in full hospitalization for less than 10 days in the care units of the Esquirol Hospital
Non inclusion criteria
- Psychiatric comorbidity (personality disorder, addiction other than tobacco, eating disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia and related disorders)
- Sensory or neurological disability
- Inability to understand the questionnaires and information related to the study
- Hospitalization under constraint, pregnancy, subjects under guardianship or curatorship, lack of social protection
Outcome Measures Primary endpoints
- AASP at V1 and V2 Secondary endpoints
- AASP, HARS, HAM-D, CORE, EES-10, SHAPS at V1 and V2
- AASP, HAM-D at V2
- AASP, ISSC
- AASP scores and socio-demographic characteristics (age, sex ratio, living environment, family status, housing)
- AASP scores and treatments at V1 and V2
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AASP | – | Other: assessment by scales |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized poeple for a major depressive disorder
Key inclusion criteria (4 listed)
- Male or female, 18 to 65 years of age
- who have given informed consent
- with a diagnosis of a major depressive disorder according to the DSM-5 criteria
- in full hospitalization for less than 10 days in the care units of the Esquirol Hospital
Key exclusion criteria (4 listed)
- Psychiatric comorbidity (personality disorder, addiction other than tobacco, eating disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia and related disorders)
- Proven sensory or neurological disability
- Inability to understand the questionnaires and information related to the study
- Hospitalization under constraint, pregnancy, subjects under guardianship or curatorship, lack of social protection
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 |
|---|---|---|
| assessment by scalesAssessment from many scales: AASP, HARS, HDRS, CORE, EES, CISS, SHAPS at V1 Assessment from many scales: AASP, HARS, HDRS, CORE, EES, SHAPS at V2 | Other | AASP |
Primary outcome
Change in Adolescent Adult Sensory Profile score
Time frame: day 0 and 3 months
measure a change in Adolescent Adult Sensory Profile score between he beginning of hospitalization and 3 months
7 secondary outcomes
Hamilton Anxiety Rating Scale score
Time frame: day 0 and 3 months
number of participants with psychomotor retardation
Time frame: day 0 and 3 months
Snaith-Hamilton pleasure scale score
Time frame: day 0 and 3 months
Coping Inventory for Stressful Situations score
Time frame: day 0
number of participants living in country
Time frame: day 0
number of participants living lonely
Time frame: day 0
Treatments
Time frame: day 0 and 3 months
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 18 Feb 2025.
- Derived from this study: PubMed 42698872Paquet A, Fiegl L, Plansont B, Bessaguet C, Gauthier A, Laplace B. Sensory Processing Profiles in Depression: Evidence of Dynamic Changes and Clinical Correlates Over 3 Months. Depress Anxiety. 2026 Sep 4;2026:8238928. doi: 10.1155/da/8238928. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Centre Hospitalier Esquirol at 1 site 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 4 inclusion and 4 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 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 in Adolescent Adult Sensory Profile score (time frame: day 0 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05686668, which also lists 1 linked publication.
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 18 Feb 2025.