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Sensory and Psychomotor Profile in Depression (DEPCOR)

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Psychomotor assessment

About this trial

This is an interventional screening trial for Major Depressive Disorder focused on measuring depression, psychomotor assessment, sensory profile, perception, motricity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

major depressive disorder according to the DSM-5
aged to 18 from 65 years old

Exclusion Criteria:

psychiatric comorbidity (bipolar, addiction, eating disorder, personality disorder, obsessional compulsive disorder)
antipsychotic drug
taken care in psychomotor therapy previously
electroconvulsive therapy
medical history of neurologic disease, neurodevelopmental disorder, sensory disability
Constraint Hospitalization
under legal protection
pregnant
lack of consent

Sites / Locations

Centre Hospitalier Esquirol

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

major depressive disorder

Control

Arm Description

psychometric scales psychomotor assessment

Outcomes

Primary Outcome Measures

% of patients with a distinctive feature at the sensory profile questionnaire from the AASP

Scores at the AASP psychomotor battery are considered. A failure is considered from a result <1SD compared to the control group.

% of patients with a failure at the muscle tone test from the NP-MOT battery

Scores at the NP-MOT psychomotor battery are considered. A failure is considered from a result <1SD compared to the control group.

% of patients with a failure at the gross motor test from the NP-MOT battery

Scores at the NP-MOT psychomotor battery are considered. A failure is considered from a result <1SD compared to the control group.

Secondary Outcome Measures

Full Information

NCT ID

NCT04031937

First Posted

June 13, 2019

Last Updated

July 19, 2021

Sponsor

Centre Hospitalier Esquirol

1. Study Identification

Unique Protocol Identification Number

NCT04031937

Brief Title

Sensory and Psychomotor Profile in Depression

Acronym

DEPCOR

Official Title

Sensory and Psychomotor Profile in Depression

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

October 23, 2018 (Actual)

Primary Completion Date

March 23, 2019 (Actual)

Study Completion Date

October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Esquirol

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Despite a possible psychomotor retardation during a depressive episode, standardized psychomotor assessment is rare. So, other possible psychomotor disorders or neurological "soft signs" are not known in depression. The investigator propose in this study to explore the psychomotor characteristics of patients with a major depressive disorder from the realization of a psychomotor assessment in comparison with adult without depressive disorder (control). It will be specifically assess muscle tone, gross motor skills, praxis, body schema and the body image and the perceptions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

depression, psychomotor assessment, sensory profile, perception, motricity

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

major depressive disorder

Arm Type

Active Comparator

Arm Description

psychometric scales psychomotor assessment

Arm Title

Control

Arm Type

Active Comparator

Arm Description

psychometric scales psychomotor assessment

Intervention Type

Other

Intervention Name(s)

Psychomotor assessment

Intervention Description

the intervention include a depression scale, an anxiety scale, a sensory profile scale, a body image questionnaire, a self-esteem questionnaire, a psychomotor retardation scale and a standardized assessment of : muscle tone (dangling and extensibility); gross motor skills (walks, jump, static balance, dynamic balance); manual performance; manual praxis; adaptation of rhythm; manual gnosis; executive function

Primary Outcome Measure Information:

Title

% of patients with a distinctive feature at the sensory profile questionnaire from the AASP

Description

Scores at the AASP psychomotor battery are considered. A failure is considered from a result <1SD compared to the control group.

Time Frame

At inclusion

Title

% of patients with a failure at the muscle tone test from the NP-MOT battery

Description

Scores at the NP-MOT psychomotor battery are considered. A failure is considered from a result <1SD compared to the control group.

Time Frame

At inclusion

Title

% of patients with a failure at the gross motor test from the NP-MOT battery

Description

Scores at the NP-MOT psychomotor battery are considered. A failure is considered from a result <1SD compared to the control group.

Time Frame

At inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: major depressive disorder according to the DSM-5 aged to 18 from 65 years old Exclusion Criteria: psychiatric comorbidity (bipolar, addiction, eating disorder, personality disorder, obsessional compulsive disorder) antipsychotic drug taken care in psychomotor therapy previously electroconvulsive therapy medical history of neurologic disease, neurodevelopmental disorder, sensory disability Constraint Hospitalization under legal protection pregnant lack of consent

Facility Information:

Facility Name

Centre Hospitalier Esquirol

City

Limoges

ZIP/Postal Code

87000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35841086

Citation

Paquet A, Lacroix A, Calvet B, Girard M. Psychomotor semiology in depression: a standardized clinical psychomotor approach. BMC Psychiatry. 2022 Jul 15;22(1):474. doi: 10.1186/s12888-022-04086-9.

Results Reference

derived

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Sensory and Psychomotor Profile in Depression

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