Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

Psychiatric Disorders Clinical Trial

— RIP-LC  

Official title:

Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125083
• Other study ID #: CHU-316
• Secondary ID: 2017-A00336-47
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: October 24, 2018

Study information

• Verified date: August 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 24, 2018
• Est. primary completion date: October 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Inflammation
• Mental Disorders
• Problem Behavior
• Psychiatric Disorders
• Skin Restricted Lupus

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Société Française de Cardiologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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	Difference in cytokine concentration between SRL patients with and without psychiatric disorders	comparison of plasma TNFa, IFNa, IFN?, IL1, IL1?, IL2, IL6, IL4, IL8, IL10, IL17, IL18 and CRP 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)