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

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

Psychiatric Disorders
Skin Restricted Lupus

Treatments

Biological: Biological dosage from plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT03125083
2017-A00336-47 (Other Identifier)
CHU-316

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

skin-restricted lupus (SRL) patients
Experimental group
Description:
Role of inflammation in psychiatric disorders in patients with cutaneous lupus
Treatment:
Biological: Biological dosage from plasma

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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