Depressive DisorderESPRI-PSYNCT06036160
Feasibility of Integrated Care of Depression in Primary Care Pathways
A study testing Integrated care in people with Depressive Disorder, run by Association De La Msp Pasteur.
Trial summary
This protocol is a feasibility study of an integrated primary care pathway for patients suffering from difficult-to-treat depression. 50 patients will be recruited and followed for two years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Integrated care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Nov 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 years
- Good understanding of french language
- Major depressive disorder based on DSM-V criteria
- MADRS > 19
- FAilure of two antidepressants during 6wks at standard minimal dose
Who cannot join
- Pregnancy or lactating
- People under tutelage
- bipolar disorder
- no health insurance
- neurological disorders
- contra-indication to physical activity
- high suicidal risk
- first degree history of bipolar disorder, schizophrenia, autism spectrum disorder
About this study
Official title: Evaluation de Soins Primaires Intégrés en Psychiatrie
This protocol is a feasibility study of an integrated primary care pathway for patients suffering from difficult-to-treat depression. 50 patients will be recruited and followed for two years.
- Conditions
- Depressive Disorder
- Being tested
- Integrated care
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated careOther
Psychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Integrated care | Experimental | Not described Receives: Other: Integrated care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients completing the study per-protocol
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association De La Msp Pasteur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036160
- Sponsor's protocol ID
- 202201
- Acronym
- ESPRI-PSY
- Status last verified
- Aug 2024
- First submitted
- 5 Sep 2023
- Last updated
- 6 Aug 2024
- Results posted
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de Soins Primaires Intégrés en Psychiatrie
- ClinicalTrials.gov ID
- NCT06036160
- Acronym / sponsor ID
- ESPRI-PSY / 202201
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Association De La Msp PasteurUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 13 Sep 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 protocol is a feasibility study of an integrated primary care pathway for patients suffering from difficult-to-treat depression. 50 patients will be recruited and followed for two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated care | Experimental | Other: Integrated care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-65 years
- Good understanding of french language
- Major depressive disorder based on DSM-V criteria
- MADRS > 19
- FAilure of two antidepressants during 6wks at standard minimal dose
Key exclusion criteria (8 listed)
- Pregnancy or lactating
- People under tutelage
- bipolar disorder
- no health insurance
- neurological disorders
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 |
|---|---|---|
| Integrated carePsychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation | Other | Integrated care |
Primary outcome
Percentage of patients completing the study per-protocol
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated care in people with Depressive Disorder, run by Association De La Msp Pasteur.
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 8 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Percentage of patients completing the study per-protocol (time frame: 3 years). 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 6 Aug 2024.