Depressive EpisodeMINDDENCT05654948
Characterisation of Fundamental Decision Making in People Suffering From a Characterised Depressive Episode
An observational study of Depressive Episode, run by University Hospital, Tours at 1 site in France.
Trial summary
The investigators will include patients suffering from Major Depressive Disorder (MDD), in episode. The patients will undertake neuropsychological tasks evaluating executive function and clinical assessment related to depressive symptoms, anxiety, transdiagnostic symptoms and psychological skills. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Episode
- What is being tested?
- computerised cognitive performance test : MindPulse
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2023to 25 Apr 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: people suffering from a characterised depressive episode
Who may be able to join
- Age between 18 and 65 years.
- Diagnosis of a depressive episode according to DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0 according to DSM-5).
- No evidence of bipolar disorder or schizophrenia, confirmed by the MINI.
- No dementing neurological disease.
- No guardianship or trusteeship
Who cannot join
- Opposition to data processing
- Depressive episode in the context of a known bipolar disorder or schizophrenic illness
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will include patients suffering from Major Depressive Disorder (MDD), in episode. The patients will undertake neuropsychological tasks evaluating executive function and clinical assessment related to depressive symptoms, anxiety, transdiagnostic symptoms and psychological skills.
Read the detailed description
The investigators will include patients suffering from MDD, in episode. The patients will be evaluated with the MINI-7 interview. Then, the participants will undertake different neuropsychological tasks evaluating executive function: the stroop task, the D2 tasks, the finger tapping test and the mindpulse. The participants will also undertake clinical evaluation the MADRS, the Transdiagnostic Skills Scale, the Symptomatic Transdiagnostic Test, the STAI and the Severity Insomnia Indexes. The investigators will perform correlational analysis between the neuropsychological tasks and the clinical evaluations. The investigators will also compare the predictive power of the different neuropsychological tasks on depressive symptoms.
- Conditions
- Depressive Episode
- Being tested
- computerised cognitive performance test : MindPulse
- Keywords
- depression, fundamental decision, computerised cognitive performance test
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerised cognitive performance test : MindPulseOther
Also called MindPulse
In practice, this tool measures the speed at which an individual reacts to the appearance of a simple image on a screen with instructions to react only to certain images. It thus makes it possible to measure the speed of information processing, attention, executive functions and reaction to difficulty
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS score
The severity of the depression will be assessed using the MADRS score. Montgomery-Asberg Depression Scale (MADRS) The scale has 10 items rated from 0 to 6.
0 to 6 points: the patient is considered healthy. 7 to 19 points: the patient is considered to be in mild depression. 20 to 34 points: the patient is considered to be in moderate depression. > 34 points: the patient is considered to be in severe depression.
Measured: baseline
Simple reaction time (SRT) obtained at the MindPulse test
The "simple reaction time" (SRT) is the reaction time to the first test (the subject releases the mouse click as quickly as possible when an image appears) , it contains the time needed to perceive and analyse the image, to formulate the response and to execute the motor response.
Measured: Baseline
Go/NoGo score obtained at the MindPulse test
reaction time with a categorisation where the subject must react or not react (Go/NoGo) according to the categorical target, in this case a light or dark colour (white coloured image or grey coloured image).
Measured: Baseline
Executive speed (ES) obtained at the MindPulse test
The ES Score corresponds to the Executive Speed, i.e. the average time of categorisation of the subject.
Measured: Baseline
Reaction to difficulty obtained at the MindPulse test
It corresponds to the adaptation of the subject to the level of difficulty. The shift of the circle above the blue rectangle indicates a higher than expected slowing down in reaction to the difficulty of the instruction, while a shift below the blue rectangle indicates that the participant is not slowing down enough in response to the difficulty and is at risk of making mistakes.
Measured: Baseline
Secondary outcomes (7)
Level of anxiety
measured by a self-questionnaire : State Trait Anxiety Inventory (STAI) 40 items rated from 1 to 4
Measured: Baseline
clinical characterisation
Measured by a scale : Transdiagnostic Skills Scale (T2S) 42 items rated from 1 to 7
Measured: Baseline
clinical characterisation
Measured by a questionnaire : Transdiagnostic Evaluation Scale (ETE) 66 items rated from 1 to 7
Measured: Baseline
insomnia severity
Measured by an insomnia severity index (ISI) 5 items rated from 0 to 4
Measured: Baseline
Stroop test
standardised cognitive assessment is measured by neuropsycological tests as stroop test
Measured: Baseline
D2R
standardised cognitive assessment is measured by neuropsycological tests as D2R test that measures the concentration
Measured: Baseline
Finger tapping test
standardised cognitive assessment is measured by neuropsycological tests as Finger tapping test rated from 0 to 4
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start9 Feb 2023
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive EpisodeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wissam EL HAGE, Principal investigator, CHU Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654948
- Sponsor's protocol ID
- DR220190-MINDDE
- Acronym
- MINDDE
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Fundamental Decision Making in People Suffering From a Characterised Depressive Episode
- ClinicalTrials.gov ID
- NCT05654948
- Acronym / sponsor ID
- MINDDE / DR220190-MINDDE
- Conditions
- Depressive Episode
- Keywords
- depression, fundamental decision, computerised cognitive performance test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 16 Dec 2022 (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.
The investigators will include patients suffering from Major Depressive Disorder (MDD), in episode. The patients will undertake neuropsychological tasks evaluating executive function and clinical assessment related to depressive symptoms, anxiety, transdiagnostic symptoms and psychological skills.
Detailed description
The investigators will include patients suffering from MDD, in episode. The patients will be evaluated with the MINI-7 interview. Then, the participants will undertake different neuropsychological tasks evaluating executive function: the stroop task, the D2 tasks, the finger tapping test and the mindpulse. The participants will also undertake clinical evaluation the MADRS, the Transdiagnostic Skills Scale, the Symptomatic Transdiagnostic Test, the STAI and the Severity Insomnia Indexes. The investigators will perform correlational analysis between the neuropsychological tasks and the clinical evaluations. The investigators will also compare the predictive power of the different neuropsychological tasks on depressive symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people suffering from a characterised depressive episode
Key inclusion criteria (5 listed)
- Age between 18 and 65 years.
- Diagnosis of a depressive episode according to DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0 according to DSM-5).
- No evidence of bipolar disorder or schizophrenia, confirmed by the MINI.
- No dementing neurological disease.
- No guardianship or trusteeship
Key exclusion criteria (2 listed)
- Opposition to data processing
- Depressive episode in the context of a known bipolar disorder or schizophrenic illness
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 |
|---|---|---|
| computerised cognitive performance test : MindPulseAlso: MindPulseIn practice, this tool measures the speed at which an individual reacts to the appearance of a simple image on a screen with instructions to react only to certain images. It thus makes it possible to measure the speed of information processing, attention, executive functions and reaction to difficulty | Other | – |
Primary outcome
MADRS score
Time frame: baseline
The severity of the depression will be assessed using the MADRS score. Montgomery-Asberg Depression Scale (MADRS) The scale has 10 items rated from 0 to 6. 0 to 6 points: the patient is considered healthy. 7 to 19 points: the patient is considered to be in mild depression. 20 to 34 points: the patient is considered to be in moderate depression. > 34 points: the patient is considered to be in severe depression.
Simple reaction time (SRT) obtained at the MindPulse test
Time frame: Baseline
The "simple reaction time" (SRT) is the reaction time to the first test (the subject releases the mouse click as quickly as possible when an image appears) , it contains the time needed to perceive and analyse the image, to formulate the response and to execute the motor response.
Go/NoGo score obtained at the MindPulse test
Time frame: Baseline
reaction time with a categorisation where the subject must react or not react (Go/NoGo) according to the categorical target, in this case a light or dark colour (white coloured image or grey coloured image).
Executive speed (ES) obtained at the MindPulse test
Time frame: Baseline
The ES Score corresponds to the Executive Speed, i.e. the average time of categorisation of the subject.
Reaction to difficulty obtained at the MindPulse test
Time frame: Baseline
It corresponds to the adaptation of the subject to the level of difficulty. The shift of the circle above the blue rectangle indicates a higher than expected slowing down in reaction to the difficulty of the instruction, while a shift below the blue rectangle indicates that the participant is not slowing down enough in response to the difficulty and is at risk of making mistakes.
7 secondary outcomes
Level of anxiety
Time frame: Baseline
clinical characterisation
Time frame: Baseline
clinical characterisation
Time frame: Baseline
insomnia severity
Time frame: Baseline
Stroop test
Time frame: Baseline
D2R
Time frame: Baseline
Finger tapping test
Time frame: Baseline
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 9 Dec 2024.
- 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.
Wissam EL HAGE principal investigator
CHU Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Episode, run by University Hospital, Tours 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 5 inclusion and 2 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 9 Dec 2024. 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?
MADRS score (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024.