Depressive EpisodePRADESHNCT05678907
Predictive Value of the DD4 Questionnaire on Depressive Relapse After Hospitalization
An observational study of Depressive Episode, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
This is a prospective, longitudinal, single-center observational study of data from the medical records of patients hospitalized after a characterized depressive episode and reviewed three months after hospital discharge, as part of a normally scheduled evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Episode
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2023to 28 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for a characterized depressive episode and considered in remission at discharge.
Who may be able to join
- Patient 18 years of age or older, having been informed of the research
- Patient hospitalized at the Auzon Clinic for a characterized depressive episodé (isolated episode or recurrent depressive disorder)
- Discharged from hospitalization
- Considered in remission (total or partial) and with a MADRS score < 20
Who cannot join
- Patient hospitalized for < 15 days
- Patient with bipolar depression
- Patient with a psychotic disorder
- Patient using narcotics with a "moderate to severe" severity
- Patient previously included in this study
- Patient under court protection, guardianship or curatorship
- Patient unablé to respond correctly to a depression self-assessment questionnaire
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique de l'Auzon
La Roche-Blanche, 63670
Anne-Marie TRONCHE, MD, 04 73 79 84 46 ext. 33, a.tronche@ramsaygds.fr
Jean-Luc DUCHER, MD
About this study
This is a prospective, longitudinal, single-center observational study of data from the medical records of patients hospitalized after a characterized depressive episode and reviewed three months after hospital discharge, as part of a normally scheduled evaluation.
Read the detailed description
Patients in the study were hospitalized following a characterized depressive episode. The study is based on a review of these patients' medical records and data from the three-month assessment. No additional assessments are planned.
- Conditions
- Depressive Episode
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive episode relapse
Relapse within three months of hospitalization
Measured: Month 3
Secondary outcomes (2)
Psychic symptoms of depression
The Multidimensional Self-Questionnaire for Depression Assessment DD4 (Ducher's Depression Scale) is presented in the form of four modules.
Each module consists of 15 identical questions (I feel sad, I suffer morally...).
The formulation of the questions allows for evaluation from 0 to 4 in different dimensions:
DD4 A: Global Evaluation (not at all true, a little true, rather true, very true, completely true) DD4 F: Frequency Evaluation (never, sometimes, often, very often, permanently) DD4 I: Intensity Evaluation (not at all, slightly, fairly, a lot, enormously) DD4 M: Maximal Evaluation (uses the criteria of the global evaluation, but during the moments when the patient feels the saddest or most depressed). An additional question asks about the frequency of these periods (never, sometimes, often, very often, permanently).
Measured: Month 3
Depressive symptomology
Measured with the Montgomery and Asberg (MADRS) scale
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start2 Jan 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
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 GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678907
- Sponsor's protocol ID
- COS-RGDS-2022-06-054
- Acronym
- PRADESH
- Status last verified
- Jun 2024
- First submitted
- 22 Dec 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the DD4 Questionnaire on Depressive Relapse After Hospitalization
- ClinicalTrials.gov ID
- NCT05678907
- Acronym / sponsor ID
- PRADESH / COS-RGDS-2022-06-054
- Conditions
- Depressive Episode
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 10 Jan 2023 (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.
This is a prospective, longitudinal, single-center observational study of data from the medical records of patients hospitalized after a characterized depressive episode and reviewed three months after hospital discharge, as part of a normally scheduled evaluation.
Detailed description
Patients in the study were hospitalized following a characterized depressive episode. The study is based on a review of these patients' medical records and data from the three-month assessment. No additional assessments are planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for a characterized depressive episode and considered in remission at discharge.
Key inclusion criteria (4 listed)
- Patient 18 years of age or older, having been informed of the research
- Patient hospitalized at the Auzon Clinic for a characterized depressive episodé (isolated episode or recurrent depressive disorder)
- Discharged from hospitalization
- Considered in remission (total or partial) and with a MADRS score < 20
Key exclusion criteria (7 listed)
- Patient hospitalized for < 15 days
- Patient with bipolar depression
- Patient with a psychotic disorder
- Patient using narcotics with a "moderate to severe" severity
- Patient previously included in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depressive episode relapse
Time frame: Month 3
Relapse within three months of hospitalization
2 secondary outcomes
Psychic symptoms of depression
Time frame: Month 3
Depressive symptomology
Time frame: Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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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.
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 GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive episode relapse (time frame: Month 3). 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 1 Jul 2024.