DepressionInDepNCT02847533
Inflammatory Markers and Resistant Depression
A study testing blood sample and psychometric scales in people with Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study focuses on blood inflammatory markers (pro-inflammatory cytokines, anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant unipolar depression in comparison with non-resistant unipolar depressed patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- blood sample and psychometric scales
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- group 1: Patients with resistant MDD (at least 2 failed treatments for the current episode) ,current treatment with IRS or IRSNA,
- group 2: patients with MDD remission after response to an antidepressant treatment.
Who cannot join
- comorbid somatic or psychiatric disorders: chronic or acute inflammatory diseases, previous treatment with brain stimulation for the current episode, legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Besançon
Besançon, 25000
Sophie Depierre, 03841218745, sdepierre@chu-besancon.fr
Emmanuel Haffen, MD PhD
About this study
This study focuses on blood inflammatory markers (pro-inflammatory cytokines, anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant unipolar depression in comparison with non-resistant unipolar depressed patients.
- Conditions
- Depression
- Being tested
- blood sample, psychometric scales
- Keywords
- resistant depression, inflammation
- Medical subject headings
- Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
blood sample for concentration levels of inflammatory markers
psychometric scalesBehavioural
Mini international interview MADRS, C-SSRS, QIDS-SR, BIS-10, BDHI, BART, ERD
| Study group | Role | What they receive |
|---|---|---|
| resistant depression | Other | patients suffering from resistant unipolar depression (at least 2 failed antidepressant treatments for the current episode) Receives: Procedure: blood sample; Behavioral: psychometric scales |
| non resistant depression | Other | patients in remission from unipolar depressive disorder Receives: Procedure: blood sample; Behavioral: psychometric scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasmatic concentration of Interleukin 6
Measured: at patient inclusion
Secondary outcomes (5)
concentration of proinflammatory cytokine
Expression intensity of monocytes costimulation molecules
Measured: at patient inclusion
concentration of antiinflammatory cytokine
Measured: at patient inclusion
functional polymorphisms of expression genes of inflammatory proteins
Measured: at patient inclusion
plasmatic concentration of Retinoid X receptor signaling pathway
Measured: at patient inclusion
Expression rate of monocytes costimulation molecules
Measured: at patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Haffen, MD PhD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847533
- Sponsor's protocol ID
- API/2014/50
- Acronym
- InDep
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Markers and Resistant Depression
- ClinicalTrials.gov ID
- NCT02847533
- Acronym / sponsor ID
- InDep / API/2014/50
- Conditions
- Depression
- Keywords
- resistant depression, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- 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 study focuses on blood inflammatory markers (pro-inflammatory cytokines, anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant unipolar depression in comparison with non-resistant unipolar depressed patients.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistant depression | Other | Procedure: blood sample, Behavioral: psychometric scalespatients suffering from resistant unipolar depression (at least 2 failed antidepressant treatments for the current episode) |
| non resistant depression | Other | Procedure: blood sample, Behavioral: psychometric scalespatients in remission from unipolar depressive disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- group 1: Patients with resistant MDD (at least 2 failed treatments for the current episode) ,current treatment with IRS or IRSNA,
- group 2: patients with MDD remission after response to an antidepressant treatment.
Key exclusion criteria (1 listed)
- comorbid somatic or psychiatric disorders: chronic or acute inflammatory diseases, previous treatment with brain stimulation for the current episode, legal protection
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 |
|---|---|---|
| blood sampleblood sample for concentration levels of inflammatory markers | Procedure or surgery | non resistant depression, resistant depression |
| psychometric scalesMini international interview MADRS, C-SSRS, QIDS-SR, BIS-10, BDHI, BART, ERD | Behavioural | non resistant depression, resistant depression |
Primary outcome
plasmatic concentration of Interleukin 6
Time frame: at patient inclusion
5 secondary outcomes
concentration of proinflammatory cytokine
Time frame: at patient inclusion
concentration of antiinflammatory cytokine
Time frame: at patient inclusion
functional polymorphisms of expression genes of inflammatory proteins
Time frame: at patient inclusion
plasmatic concentration of Retinoid X receptor signaling pathway
Time frame: at patient inclusion
Expression rate of monocytes costimulation molecules
Time frame: at patient inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- 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.
Emmanuel Haffen, MD PhD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and psychometric scales in people with Depression, run by Centre Hospitalier Universitaire de Besancon 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 1 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 28 Jul 2016. 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?
Contact Emmanuel Haffen, MD PhD (0033381218388, ehaffen@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasmatic concentration of Interleukin 6 (time frame: at patient inclusion). 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 28 Jul 2016; AzTrials last refreshed its copy on 29 Oct 2026.