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

Primary Purpose

Skin Restricted Lupus, Psychiatric Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological dosage from plasma
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Skin Restricted Lupus focused on measuring Skin restricted lupus, Psychiatric disorders, Inflammation, Kynurenine pathway

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

skin-restricted lupus (SRL) patients

Arm Description

Role of inflammation in psychiatric disorders in patients with cutaneous lupus

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Difference in cytokine concentration between SRL patients with and without psychiatric disorders
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.

Full Information

First Posted
April 13, 2017
Last Updated
January 5, 2023
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Société Française de Cardiologie
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1. Study Identification

Unique Protocol Identification Number
NCT03125083
Brief Title
Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus
Acronym
RIP-LC
Official Title
Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
October 24, 2018 (Actual)
Study Completion Date
October 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Société Française de Cardiologie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Restricted Lupus, Psychiatric Disorders
Keywords
Skin restricted lupus, Psychiatric disorders, Inflammation, Kynurenine pathway

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
skin-restricted lupus (SRL) patients
Arm Type
Experimental
Arm Description
Role of inflammation in psychiatric disorders in patients with cutaneous lupus
Intervention Type
Biological
Intervention Name(s)
Biological dosage from plasma
Intervention 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.
Primary Outcome Measure Information:
Title
Difference in IDO activation and neurotransmitters synthesis inhibition between SRL patients with and without psychiatric disorders.
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Difference in kynurenine pathway activation between SRL patients with and without psychiatric disorders.
Description
comparison of plasma kynurenic acid / kynurenine and quinolinic acid / kynurenine ratios between SRL patients with and without psychiatric disorders.
Time Frame
Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)
Title
Difference in cytokine concentration between SRL patients with and without psychiatric disorders
Description
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.
Time Frame
Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle JALENQUES
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

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