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Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03125083
Acronym
RIP-LC
Enrollment
40
Registered
2017-04-24
Start date
2017-05-05
Completion date
2018-10-24
Last updated
2023-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychiatric Disorders, Skin Restricted Lupus

Keywords

Skin restricted lupus, Psychiatric disorders, Inflammation, Kynurenine pathway

Brief 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. 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.

Interventions

BIOLOGICALBiological dosage from plasma

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.

Sponsors

Société Française de Cardiologie
CollaboratorOTHER
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in IDO activation and neurotransmitters synthesis inhibition between SRL patients with and without psychiatric disorders.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.

Secondary

MeasureTime frameDescription
Difference in kynurenine pathway activation between SRL patients with and without psychiatric disorders.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 kynurenic acid / kynurenine and quinolinic acid / kynurenine ratios between SRL patients with and without psychiatric disorders.
Difference in cytokine concentration between SRL patients with and without psychiatric disordersBlood 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 TNFα, IFNα, IFNγ, IL1, IL1ᵦ, IL2, IL6, IL4, IL8, IL10, IL17, IL18 and CRP between SRL patients with and without psychiatric disorders.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026