Clinical trial NCT01649479: Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome
Official title: Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Antiphospholipid Syndrome
Keywords: Obstetrical antiphospholipid syndrome
Thrombophilia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Not postmenopausal
* Able to understand the nature, purpose and methodology of the study and agreed to cooperate in clinical and biological assessments
* Available for 12 weeks of follow-up
* Isolated obstetric morbidity, defined by at least one of the following criteria:
* at least three consecutive episodes of unexplained, early, embryonic miscarriage, which occurred before the 10th week of pregnancy, with normal maternal anatomic and hormonal assessment, normal karyotypes for both biological parents;
* at least one unexplained fetal death, defined as occurring after the 10th week of pregnancy, involving a morphologically normal fetus as documented by ultrasound examination or direct examination of the conceptus;
* at least one premature birth of a morphologically normal fetus before the 34th week of pregnancy, because of: (1) pre-eclampsia, severe or not, according to the American College of Obstetrics and Gynecology, ACOG, 2002; (2)documented placental insufficiency, defined by the following parameters: (2a) abnormal or non-reassuring fetal monitoring exam, in general a non-reactive absence-of-fetal-stress test (fetal monitoring), suggesting fetal hypoxemia; (2b) a Doppler examination of uterine arteries suggesting fetal hypoxemia, ie the absence of end-diastolic flow in the umbilical arteries; (2c) oligohydramnios, that is to say, an amniotic flow index \<5 cm; (2d) indexed birth weight for gestational age and sex below the 10th percentile.
* Patient willing to accept psychological and medical care over the long term

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient or breastfeeding
* Systemic vascular morbidity, defined by the following criteria: (1) Any personal history of venous thromboembolism, defined by the occurrence of deep phlebitis and / or a pulmonary embolism, diagnosed by means of objective exploration ; (2)Any personal history of superficial venous thrombosis; (3) Any personal history of clinical, symptomatic relapses of arterial insufficiency - the latter may be cerebro vascular in nature (transient ischemic attack, stroke, etc..), coronary in nature (angina, myocardial infarction, etc..) or otherwise (claudication mesenteric, etc.), and objectively diagnosed.
* Systemic inflammatory disease: any history of systemic disease, lupus erythematosus or other connective, rheumatoid arthritis
* Any history of neoplastic disease
* Chronic antithrombotic treatment taken before the occurrence of obstetrical complications
* Any chronic immunosuppressive therapy or immunomodulatory therapy (eg corticosteroids, hydroxochloroquine or intravenous immunoglobulins)
* Fetal loss can be explained by infectious, metabolic (including rates of fasting blood glucose\> 7 mmol / L), anatomical or hormonal factors
* History of infection with hepatitis B, hepatitis C or HIV
* Taking antipsychotic treatment potentially implicated in biological autoimmune abnormalities

Primary outcomes:
measure: presence/absence of (lifetime) psychiatric symptoms
timeFrame: baseline (transversal); Day 0
Secondary outcomes:
measure: presence/absence of (current) psychiatric symptoms
timeFrame: baseline (transversal); Day 0
measure: SCID-1 score
timeFrame: baseline (transversal); Day 0 or up to Day 15
measure: MDQ score
timeFrame: baseline (transversal); Day 0
measure: BDI score
timeFrame: baseline (transversal); Day 0 or up to Day 15
measure: IDS-C score
timeFrame: baseline (transversal); Day 0 or up Day 15
measure: presence/absence of lupus anticoagulant
timeFrame: baseline (transversal); Day 0
measure: presence/absence of anticardiolipid antibodies
timeFrame: baseline (transversal); Day 0
measure: presence/absence of anti-beta2-glycoprotein 1 antibodies
timeFrame: baseline (transversal); Day 0
measure: deficit in antithrombin: yes/no
timeFrame: baseline (transversal); Day 0
measure: Deficit in protein C: yes/no
timeFrame: baseline (transversal); Day 0
measure: Deficit in protein S: yes/no
timeFrame: baseline (transversal); Day 0
measure: Excess of FVIII: yes/no
timeFrame: baseline (transversal); Day 0
measure: Excess of homocystein? yes/no
timeFrame: baseline (transversal); Day 0
measure: presence/absence of allele F5 1691A
timeFrame: baseline (transversal); Day 0
measure: presence/absence of allele F2 20210A
timeFrame: baseline (transversal); Day 0
measure: presence/absence of allele JAK2 617F
timeFrame: baseline (transversal); Day 0
measure: Age at beginning of psychiatric symptoms
timeFrame: baseline (transversal); Day 0
measure: Age at beginning of APL or thrombophilia symptoms
timeFrame: baseline (transversal); Day 0
Other outcomes:
Locations:
city: Marseille Cedex 20
country: France
facility: APHM - Hôpital Nord
city: Marseille Cedex 5
country: France
facility: APHM - Hôpital de la Conception
city: Marseille cedex 5
country: France
facility: APHM - Hôpital La Timone Adultes
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
References: