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CompletedNCT03125083RIP-LCUpdated Jan 6, 2023

Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

An interventional study of Biological dosage from plasma in Skin Restricted Lupus and Psychiatric Disorders, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-06.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Skin Restricted Lupus
  • Psychiatric Disorders

Keywords

  • Skin restricted lupus
  • Psychiatric disorders
  • Inflammation
  • Kynurenine pathway
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    skin-restricted lupus (SRL) patients

    Role of inflammation in psychiatric disorders in patients with cutaneous lupus

    Biological: Biological dosage from plasma

Interventions

  • BiologicalBiological 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.

06

What researchers measure

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.

    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 outcomes

  1. 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.

    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)

  2. 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.

    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)

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03125083
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Société Française de Cardiologie
Responsible party
Sponsor
First posted
Apr 24, 2017
Start date
May 5, 2017
Primary completion
Oct 24, 2018
Completion
Oct 24, 2018
Last update
Jan 6, 2023

Study contacts

Isabelle JALENQUES
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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