Evolution of the Sensory Profile in Depression

Major Depressive Disorder Clinical Trial

— DEPSENS  

Official title:

Evolution of the Sensory Profile in Depression

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05686668
• Other study ID #: CHEsquirol
• Status: Enrolling by invitation
• Start date: January 10, 2022
• Est. completion date: January 10, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Esquirol
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.). 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).

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

1. AASP, HARS, HAM-D, CORE, EES-10, SHAPS at V1 and V2

2. AASP, HAM-D at V2

3. AASP, ISSC

4. AASP scores and socio-demographic characteristics (age, sex ratio, living environment, family status, housing)

5. AASP scores and treatments at V1 and V2

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• assessment by scales
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

Locations

Country	Name	City	State
France	CH Esquirol	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Esquirol

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adolescent Adult Sensory Profile score	measure a change in Adolescent Adult Sensory Profile score between he beginning of hospitalization and 3 months	day 0 and 3 months
Secondary	Hamilton Anxiety Rating Scale score	measure a change in Adolescent Adult Sensory Profile score according to the HARS	day 0 and 3 months
Secondary	number of participants with psychomotor retardation	measure a change in Adolescent Adult Sensory Profile score according to the psychomotor retardation-CORE scale	day 0 and 3 months
Secondary	Snaith-Hamilton pleasure scale score	measure a change in Adolescent Adult Sensory Profile score according to SHAPS score	day 0 and 3 months
Secondary	Coping Inventory for Stressful Situations score	the distribution of processing patterns of sensory profiles were compared according to coping styles based on CISS score	day 0
Secondary	number of participants living in country	compare the Adolescent Adult Sensory Profile score according to living environment (country or town)	day 0
Secondary	number of participants living lonely	compare the Adolescent Adult Sensory Profile score according to the family status (living alone or with people)	day 0
Secondary	Treatments	measure a change in Adolescent Adult Sensory Profile score according to the traitments (antidepressant, anxiolytic, neuroleptic, psycho-corporal therapy)	day 0 and 3 months