The main objective of this study is to estimate the lifetime prevalence of major psychiatric disorders (axis I DSM-IV; Diagnostic and Statistical Manual of Mental Disorders, version IV) in a large sample of patients with developed clinical signs of pure obstetrical antiphospholipid syndrome (suspected APS).
The secondary objectives of this study are: A. To compare the lifetime prevalence of these major disorders between groups; B. To assess the association of different, targeted, qualitative biomarkers with clinical symptomatology; C. To assess the association between the presence of "transitory APS" and the presence of psychiatric disorders; D. Estimate and compare the current prevalence (= the day of assessment) of major psychiatric disorders in the sample of patients who developed clinical signs of obstetrical APS; E. Estimate the current prevalence (= the day of assessment) and intensity of major depressive episodes (MDE) in the sample of patients; F. Compare the prevalence of current MDE and the intensity of depressive symptoms present between groups; G. Estimate and compare the (lifetime and current) prevalence by category of psychiatric disorders (psychotic, anxiety, mood, etc..) in the APS group with that in the thrombophilic group and the remaining group; H. To study the average age of onset of psychiatric disorders and clinical manifestations of APS in the sample of patients who developed clinical signs of obstetrical APS; I. Compare the mean ages between groups; J. Compare the mean age at onset of psychiatric disorders with the average age of the first clinical manifestation of the disease in the group of women with APS.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
20
Each patient will be tested for antiphospholipid antibodies.
Bloodwork will be drawn up for: * antithrombin, protein C, protein S * Factor V Leiden polymorphisms (F5 1691A) * prothrombin 20210A gene polymorphism (F2 20210A) * JAK2 617F Mutation * Homocysteine * Factor VIII
During this consultation, the Mini International Neuropsychiatric Interview will be used to screen for psychiatric symptoms. Should the latter be detected, a further consult with a psychiatrist or a psychologist will be organized; this second consult will include the Mood Disorder Questionnaire (MDQ), the Beck Depression Inventory (BDI), the Inventory for Depressive Symptomatology - Clinician (IDS-C) and the Structured Clinical Interview for Disorders (SCID, DSM-IV).
APHM - Hôpital de la Conception
Marseille, France
APHM - Hôpital La Timone Adultes
Marseille, France
APHM - Hôpital Nord
Marseille, France
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, France
presence/absence of (lifetime) psychiatric symptoms
The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (lifetime) psychiatric symptoms.
Time frame: baseline (transversal); Day 0
presence/absence of (current) psychiatric symptoms
The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (current) psychiatric symptoms.
Time frame: baseline (transversal); Day 0
SCID-1 score
Structured Clinical Interview for Disorders (SCID-1) score for patients with a positive MINI evaluation.
Time frame: baseline (transversal); Day 0 or up to Day 15
MDQ score
Mood Disorder Questionnaire score
Time frame: baseline (transversal); Day 0
BDI score
The Beck Depression Inventory (BDI) score for currently depressed patients only.
Time frame: baseline (transversal); Day 0 or up to Day 15
IDS-C score
Inventory of Depressive Symptomatology (IDS-C) for currently depressed patients.
Time frame: baseline (transversal); Day 0 or up Day 15
presence/absence of lupus anticoagulant
Time frame: baseline (transversal); Day 0
presence/absence of anticardiolipid antibodies
Time frame: baseline (transversal); Day 0
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CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
presence/absence of anti-beta2-glycoprotein 1 antibodies
Time frame: baseline (transversal); Day 0
deficit in antithrombin: yes/no
Time frame: baseline (transversal); Day 0
Deficit in protein C: yes/no
Time frame: baseline (transversal); Day 0
Deficit in protein S: yes/no
Time frame: baseline (transversal); Day 0
Excess of FVIII: yes/no
Excess of coagulation factor VIII?
Time frame: baseline (transversal); Day 0
Excess of homocystein? yes/no
Time frame: baseline (transversal); Day 0
presence/absence of allele F5 1691A
F5 1691A: allele 1691A for the factor V leiden gene
Time frame: baseline (transversal); Day 0
presence/absence of allele F2 20210A
F2 20210A: allele 20210A for the prothrombin gene
Time frame: baseline (transversal); Day 0
presence/absence of allele JAK2 617F
JAK2 617F: 617f mutation at the jak2 gene
Time frame: baseline (transversal); Day 0
Age at beginning of psychiatric symptoms
in years
Time frame: baseline (transversal); Day 0
Age at beginning of APL or thrombophilia symptoms
in years
Time frame: baseline (transversal); Day 0