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Trial record 43 of 906 for:    Lupus

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

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ClinicalTrials.gov Identifier: NCT03125083
Recruitment Status : Unknown
Verified May 2017 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : April 24, 2017
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
Société Française de Cardiologie
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Skin Restricted Lupus Psychiatric Disorders Biological: Biological dosage from plasma Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125083


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Isabelle JALENQUES         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Société Française de Cardiologie
Investigators
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Principal Investigator: Isabelle JALENQUES University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03125083     History of Changes
Other Study ID Numbers: CHU-316
2017-A00336-47 ( Other Identifier: 2017-A00336-47 )
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Skin restricted lupus
Psychiatric disorders
Inflammation
Kynurenine pathway
Additional relevant MeSH terms:
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Disease
Inflammation
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms