- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04031937
Sensory and Psychomotor Profile in Depression (DEPCOR)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Limoges, France, 87000
- Centre Hospitalier Esquirol
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: major depressive disorder
psychometric scales psychomotor assessment
|
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
|
|
ACTIVE_COMPARATOR: Control
psychometric scales psychomotor assessment
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
% of patients with a distinctive feature at the sensory profile questionnaire from the AASP
Time Frame: At inclusion
|
Scores at the AASP psychomotor battery are considered.
A failure is considered from a result <1SD compared to the control group.
|
At inclusion
|
|
% of patients with a failure at the muscle tone test from the NP-MOT battery
Time Frame: At inclusion
|
Scores at the NP-MOT psychomotor battery are considered.
A failure is considered from a result <1SD compared to the control group.
|
At inclusion
|
|
% of patients with a failure at the gross motor test from the NP-MOT battery
Time Frame: At inclusion
|
Scores at the NP-MOT psychomotor battery are considered.
A failure is considered from a result <1SD compared to the control group.
|
At inclusion
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A02055-50
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.
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