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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04031937
Other study ID # 2018-A02055-50
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 23, 2018
Est. completion date October 15, 2019

Study information

Verified date July 2021
Source Centre Hospitalier Esquirol
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 15, 2019
Est. primary completion date March 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
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

Locations

Country Name City State
France Centre Hospitalier 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 % 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. At inclusion
Primary % 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. At inclusion
Primary % 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. At inclusion
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