- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05686668
Evolution of the Sensory Profile in Depression (DEPSENS)
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Limoges, France, 87000
- CH Esquirol
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
AASP
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
day 0 and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Anxiety Rating Scale score
Time Frame: day 0 and 3 months
|
measure a change in Adolescent Adult Sensory Profile score according to the HARS
|
day 0 and 3 months
|
number of participants with psychomotor retardation
Time Frame: day 0 and 3 months
|
measure a change in Adolescent Adult Sensory Profile score according to the psychomotor retardation-CORE scale
|
day 0 and 3 months
|
Snaith-Hamilton pleasure scale score
Time Frame: day 0 and 3 months
|
measure a change in Adolescent Adult Sensory Profile score according to SHAPS score
|
day 0 and 3 months
|
Coping Inventory for Stressful Situations score
Time Frame: day 0
|
the distribution of processing patterns of sensory profiles were compared according to coping styles based on CISS score
|
day 0
|
number of participants living in country
Time Frame: day 0
|
compare the Adolescent Adult Sensory Profile score according to living environment (country or town)
|
day 0
|
number of participants living lonely
Time Frame: day 0
|
compare the Adolescent Adult Sensory Profile score according to the family status (living alone or with people)
|
day 0
|
Treatments
Time Frame: day 0 and 3 months
|
measure a change in Adolescent Adult Sensory Profile score according to the traitments (antidepressant, anxiolytic, neuroleptic, psycho-corporal therapy)
|
day 0 and 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHEsquirol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on assessment by scales
-
Istituto Ortopedico RizzoliActive, not recruitingQuality of Life | Fatigue Syndrome, Chronic | Bone TumorItaly
-
National Research Center for Preventive MedicineRecruitingCoronary Artery Disease | DyspneaRussian Federation
-
Centre Hospitalier Universitaire DijonNot yet recruiting
-
Hospital Sao DomingosCompleted
-
University Hospital, MontpellierUnknownRestless Legs SyndromeFrance
-
The University of Hong KongOrbisRecruiting
-
Hospital de Clinicas de Porto AlegreUnknownSpinocerebellar Ataxia Type 3 | Machado-Joseph Disease | SCA3 | MJDBrazil
-
Melbourne HealthRecruitingIschemic Stroke | Intracerebral HemorrhageAustralia
-
Maastricht University Medical CenterActive, not recruitingRecurrence | Metastasis | Pathology | Cutaneous Squamous Cell CarcinomaNetherlands
-
University Hospital, LimogesTerminatedGiant Cell Arteritis in Dependency of ElderlyFrance