Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

NCT03125083 | Completed

• 2 other identifiers: CHU-3162017-A00336-47
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Restricted Lupus; Psychiatric Disorders

Keywords

Skin restricted lupus; Psychiatric disorders; Inflammation; Kynurenine pathway

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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

  Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)

Study Arms (1)

skin-restricted lupus (SRL) patients

EXPERIMENTAL

Role of inflammation in psychiatric disorders in patients with cutaneous lupus

Biological: Biological dosage from plasma

Interventions

Biological dosage from plasma BIOLOGICAL

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.

skin-restricted lupus (SRL) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Société Française de Cardiologie: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Mental Disorders; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabelle JALENQUES

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 24, 2017
• Study Start: May 5, 2017
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: January 6, 2023

Record last verified: 2019-08

Locations

FR (1)