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

January 5, 2023 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in IDO activation and 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)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in kynurenine pathway activation 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)
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)
Difference in cytokine concentration 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)
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.
Blood samples at day 1 and plasma analyses at the end of the study (when all patients will be included, up to 15 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Société Française de Cardiologie

Investigators

  • Principal Investigator: Isabelle JALENQUES, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2017

Primary Completion (Actual)

October 24, 2018

Study Completion (Actual)

October 24, 2018

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-316
  • 2017-A00336-47 (Other Identifier: 2017-A00336-47)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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