RIP-LC: Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT03125083

Collaborator

Société Française de Cardiologie (Other)

Enrollment

Location

Arm

18.9

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Restricted Lupus Psychiatric Disorders	Biological: Biological dosage from plasma	N/A

Detailed Description

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

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

Actual Study Start Date :

May 5, 2017

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: skin-restricted lupus (SRL) patients Role of inflammation in psychiatric disorders in patients with cutaneous lupus	Biological: Biological 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.

Arm

Intervention/Treatment

Experimental: skin-restricted lupus (SRL) patients

Role of inflammation in psychiatric disorders in patients with cutaneous lupus

Biological: Biological dosage from plasma

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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 TNFα, IFNα, IFNγ, IL1, IL1ᵦ, IL2, IL6, IL4, IL8, IL10, IL17, IL18 and CRP between SRL patients with and without psychiatric disorders.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.