ClinicalTrials.Veeva

Menu

Evolution of the Sensory Profile in Depression (DEPSENS)

C

Centre Hospitalier Esquirol

Status

Invitation-only

Conditions

Major Depressive Disorder

Treatments

Other: assessment by scales

Study type

Observational

Funder types

Other

Identifiers

NCT05686668
CHEsquirol

Details and patient eligibility

About

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).

Full 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

Enrollment

35 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

AASP
Treatment:
Other: assessment by scales

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems