Major Depressive DisorderDEPCORNCT04031937
Sensory and Psychomotor Profile in Depression
A study testing Psychomotor assessment in people with Major Depressive Disorder, run by Centre Hospitalier Esquirol at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Psychomotor assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2018to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- major depressive disorder according to the DSM-5
- aged to 18 from 65 years old
Who cannot join
- 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
Show all 9Show fewer
- under legal protection
- pregnant
- lack of consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Psychomotor assessment
- Keywords
- depression, psychomotor assessment, sensory profile, perception, motricity
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| major depressive disorder | Active comparator | psychometric scales psychomotor assessment Receives: Other: Psychomotor assessment |
| Control | Active comparator | psychometric scales psychomotor assessment Receives: Other: Psychomotor assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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.
Measured: 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.
Measured: 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.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start23 Oct 2018
- Primary completion23 Mar 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aude Paquet, Centre Hospitalier Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031937
- Sponsor's protocol ID
- 2018-A02055-50
- Acronym
- DEPCOR
- Status last verified
- Jul 2021
- First submitted
- 13 Jun 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35841086
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory and Psychomotor Profile in Depression
- ClinicalTrials.gov ID
- NCT04031937
- Acronym / sponsor ID
- DEPCOR / 2018-A02055-50
- Conditions
- Major Depressive Disorder
- Keywords
- depression, psychomotor assessment, sensory profile, perception, motricity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 23 Mar 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| major depressive disorder | Active comparator | Other: Psychomotor assessmentpsychometric scales psychomotor assessment |
| Control | Active comparator | Other: Psychomotor assessmentpsychometric scales psychomotor assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- major depressive disorder according to the DSM-5
- aged to 18 from 65 years old
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychomotor assessmentthe 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 | Other | Control, major depressive disorder |
Primary outcome
% 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.
% 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.
% 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Derived from this study: PubMed 35841086Paquet 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychomotor assessment in people with Major Depressive Disorder, run by Centre Hospitalier Esquirol at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients with a distinctive feature at the sensory profile questionnaire from the AASP (time frame: At inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04031937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.