Skin Restricted LupusRIP-LCNCT03125083
Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus
A study testing Biological dosage from plasma in people with Skin Restricted Lupus and Psychiatric Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Restricted Lupus, Psychiatric Disorders
- What is being tested?
- Biological dosage from plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2017to 24 Oct 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
- Diagnosis of cutaneous lupus:
- Chronic (or discoid) cutaneous lupus during activity:
- Either the typical chronic lupus plaque (associated with erythema, hyperkeratosis, atrophy) sitting on the photoexposed areas of the face and / or on the scalp; The erythematous forms in sheets are excluded in order not to include patients who may be ambiguous in diagnosis with systemic lupus.
- Either form "tumidus" of chronic lupus. Typical cutaneous histology of chronic cutaneous lupus (orthokeratosis hyperkeratosis with horny plugs, thickening of the basal membrane area (PAS staining), lymphocytic infiltrate predominantly peri-necular but possibly having lichenoid aspects with vacuolation of the epidermal basal layer and cytoids).
- sub-acute erythematous form in the course of evolution, thus defined Lesions distributed on the body's photoexposed areas, erythematous, squamous leaving scarred scars, the intensity of which is clearly aggravated by exposure to light.
- Diagnostic histology compatible with diagnosis (hyperketatose orthokeratosique, middle and / or higher dermal lymphocytic infiltrate).
- Presence of anti-Ro serum antibodies.
- Age greater than or equal to 18 years
Who cannot join
- Uncertain diagnosis of lupus
- Systemic lupus
- Presence of anti-native DNA antibodies at a rate> 1/80
- Proteinuria greater than 0.5g / 24h (or more than 3+),
- Presence of more than 3 American College of Rheumatology (ACR) criteria for the diagnosis of systemic lupus
- Other inflammatory dermatological pathology
Show all 16Show fewer
- Chronic inflammatory disease (other than lupus)
- Diabetes
- Surgery in the previous month
- Immunosuppressive therapy
- Pregnant and lactating women
- Abuse or dependence on all poisons (except tobacco and alcohol)
- Mental retardation
- Illiteracy or not sufficiently fluent in French
- Patients under legal protection
- Patients with acute inflammatory (and / or infectious, and / or traumatic) illness or who have taken an anti-inflammatory (other than for cutaneous lupus), analgesic, antihistamine or aspirin therapy within 15 days prior to inclusion Participate in the study, but will be offered to shift the inclusion. They may be included 15 days after an inflammatory disease or discontinuation of such treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin pathway). This leads to the development of psychiatric disorders.
Investigator therefore want to compare inflammation and neurotransmitter synthesis in SRL patients according to the presence or absence of psychiatric disorders.
Investigator expect a decrease in neurotransmitter synthesis and activation of the kynurenin pathway in patients with a psychiatric disorder.
Read the detailed description
The purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin pathway). This leads to the development of psychiatric disorders.
Investigator therefore want to compare inflammation and neurotransmitter synthesis in SRL patients according to the presence or absence of psychiatric disorders.
Investigator expect a decrease in neurotransmitter synthesis and activation of the kynurenin pathway in patients with a psychiatric disorder.
- Conditions
- Skin Restricted Lupus, Psychiatric Disorders
- Being tested
- Biological dosage from plasma
- Keywords
- Skin restricted lupus, Psychiatric disorders, Inflammation, Kynurenine pathway
- Medical subject headings
- Mental Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological dosage from plasmaBiological
The purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin pathway). This leads to the development of psychiatric disorders.
| Study group | Role | What they receive |
|---|---|---|
| skin-restricted lupus (SRL) patients | Experimental | Role of inflammation in psychiatric disorders in patients with cutaneous lupus Receives: Biological: Biological dosage from plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in IDO activation and neurotransmitters synthesis inhibition between SRL patients with and without psychiatric disorders.
comparison of plasma:
- kynurenine / tryptophan and 3-hydroxykynurenine / kynurenine ratios for IDO activation
- serotonin / tryptophan) et tyrosine / phenylalanine ratios for neurotransmitters synthesis inhibition between SRL patients with and without psychiatric disorders.
Measured: Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)
Secondary outcomes (2)
Difference in kynurenine pathway activation between SRL patients with and without psychiatric disorders.
comparison of plasma kynurenic acid / kynurenine and quinolinic acid / kynurenine ratios between SRL patients with and without psychiatric disorders.
Measured: Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)
Difference in cytokine concentration between SRL patients with and without psychiatric disorders
comparison of plasma TNFα, IFNα, IFNγ, IL1, IL1ᵦ, IL2, IL6, IL4, IL8, IL10, IL17, IL18 and CRP between SRL patients with and without psychiatric disorders.
Measured: Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start5 May 2017
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Restricted LupusStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française de Cardiologie
- Responsible party
- Sponsor
- Investigators
- Isabelle JALENQUES, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125083
- Sponsor's protocol ID
- CHU-316
- Other IDs
- 2017-A00336-47
- Acronym
- RIP-LC
- Status last verified
- Aug 2019
- First submitted
- 13 Apr 2017
- Last updated
- 6 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus
- ClinicalTrials.gov ID
- NCT03125083
- Acronym / sponsor ID
- RIP-LC / CHU-316
- Conditions
- Skin Restricted Lupus, Psychiatric Disorders
- Keywords
- Skin restricted lupus, Psychiatric disorders, Inflammation, Kynurenine pathway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Société Française de Cardiologie
- Study start
- 5 May 2017 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 24 Apr 2017 (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 purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin pathway). This leads to the development of psychiatric disorders.
Investigator therefore want to compare inflammation and neurotransmitter synthesis in SRL patients according to the presence or absence of psychiatric disorders.
Investigator expect a decrease in neurotransmitter synthesis and activation of the kynurenin pathway in patients with a psychiatric disorder.
Detailed description
The purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin pathway). This leads to the development of psychiatric disorders.
Investigator therefore want to compare inflammation and neurotransmitter synthesis in SRL patients according to the presence or absence of psychiatric disorders.
Investigator expect a decrease in neurotransmitter synthesis and activation of the kynurenin pathway in patients with a psychiatric disorder.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skin-restricted lupus (SRL) patients | Experimental | Biological: Biological dosage from plasmaRole of inflammation in psychiatric disorders in patients with cutaneous lupus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of cutaneous lupus:
- Either the typical chronic lupus plaque (associated with erythema, hyperkeratosis, atrophy) sitting on the photoexposed areas of the face and / or on the scalp; The erythematous forms in sheets are excluded in order not to include patients who may be ambiguous in diagnosis with systemic lupus.
- Either form "tumidus" of chronic lupus. Typical cutaneous histology of chronic cutaneous lupus (orthokeratosis hyperkeratosis with horny plugs, thickening of the basal membrane area (PAS staining), lymphocytic infiltrate predominantly peri-necular but possibly having lichenoid aspects with vacuolation of the epidermal basal layer and cytoids).
- sub-acute erythematous form in the course of evolution, thus defined Lesions distributed on the body's photoexposed areas, erythematous, squamous leaving scarred scars, the intensity of which is clearly aggravated by exposure to light.
- Diagnostic histology compatible with diagnosis (hyperketatose orthokeratosique, middle and / or higher dermal lymphocytic infiltrate).
Key exclusion criteria (16 listed)
- Uncertain diagnosis of lupus
- Systemic lupus
- Presence of anti-native DNA antibodies at a rate> 1/80
- Proteinuria greater than 0.5g / 24h (or more than 3+),
- Presence of more than 3 American College of Rheumatology (ACR) criteria for the diagnosis of systemic lupus
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 |
|---|---|---|
| Biological dosage from plasmaThe purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin pathway). This leads to the development of psychiatric disorders. | Biological | skin-restricted lupus (SRL) patients |
Primary outcome
Difference in IDO activation and neurotransmitters synthesis inhibition between SRL patients with and without psychiatric disorders.
Time frame: Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)
comparison of plasma: * kynurenine / tryptophan and 3-hydroxykynurenine / kynurenine ratios for IDO activation * serotonin / tryptophan) et tyrosine / phenylalanine ratios for neurotransmitters synthesis inhibition between SRL patients with and without psychiatric disorders.
2 secondary outcomes
Difference in kynurenine pathway activation between SRL patients with and without psychiatric disorders.
Time frame: Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)
Difference in cytokine concentration between SRL patients with and without psychiatric disorders
Time frame: Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)
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 6 Jan 2023.
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.
Isabelle JALENQUES principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological dosage from plasma in people with Skin Restricted Lupus and Psychiatric Disorders, run by University Hospital, Clermont-Ferrand 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 8 inclusion and 16 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 6 Jan 2023. 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?
Difference in IDO activation and neurotransmitters synthesis inhibition between SRL patients with and without psychiatric disorders. (time frame: Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)). 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 Jan 2023.