NCT04031937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

June 13, 2019

Last Update Submit

July 19, 2021

Conditions

Major Depressive Disorder

Keywords

depressionpsychomotor assessmentsensory profileperceptionmotricity

Outcome Measures

Primary Outcomes (3)

  • % 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

  • % 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

  • % 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

Study Arms (2)

major depressive disorder

ACTIVE COMPARATOR

psychometric scales psychomotor assessment

Other: Psychomotor assessment

Control

ACTIVE COMPARATOR

psychometric scales psychomotor assessment

Other: Psychomotor assessment

Interventions

Psychomotor assessmentOTHER

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

Controlmajor depressive disorder

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Esquirol

Limoges, 87000, France

Location

Related Publications (1)

  • 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.

    PMID: 35841086DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2019

First Posted

July 24, 2019

Study Start

October 23, 2018

Primary Completion

March 23, 2019

Study Completion

October 15, 2019

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

FR(1)