Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

Antiphospholipid Syndrome Clinical Trial

— MENT-APL-O  

Official title:

Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01649479
• Other study ID #: PHRC-I/2012/FC-01
• Secondary ID: 2012-A00705-38
• Status: Terminated
• Phase: N/A
• First received: July 23, 2012
• Last updated: March 24, 2015
• Start date: April 2013
• Est. completion date: September 2013

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Syndrome

Intervention

Biological:
• Antiphospholipid antibody tests
Each patient will be tested for antiphospholipid antibodies.
• Thrombophilia bloodwork
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

Other:
• Psychiatric evaluation
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).

Locations

Country	Name	City	State
France	APHM - Hôpital Nord	Marseille Cedex 20
France	APHM - Hôpital de la Conception	Marseille Cedex 5
France	APHM - Hôpital La Timone Adultes	Marseille cedex 5
France	CHU de Montpellier - Hôpital Saint-Eloi	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (transversal); Day 0	No
Secondary	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.	baseline (transversal); Day 0	No
Secondary	SCID-1 score	Structured Clinical Interview for Disorders (SCID-1) score for patients with a positive MINI evaluation.	baseline (transversal); Day 0 or up to Day 15	No
Secondary	MDQ score	Mood Disorder Questionnaire score	baseline (transversal); Day 0	No
Secondary	BDI score	The Beck Depression Inventory (BDI) score for currently depressed patients only.	baseline (transversal); Day 0 or up to Day 15	No
Secondary	IDS-C score	Inventory of Depressive Symptomatology (IDS-C) for currently depressed patients.	baseline (transversal); Day 0 or up Day 15	No
Secondary	presence/absence of lupus anticoagulant		baseline (transversal); Day 0	No
Secondary	presence/absence of anticardiolipid antibodies		baseline (transversal); Day 0	No
Secondary	presence/absence of anti-beta2-glycoprotein 1 antibodies		baseline (transversal); Day 0	No
Secondary	deficit in antithrombin: yes/no		baseline (transversal); Day 0	No
Secondary	Deficit in protein C: yes/no		baseline (transversal); Day 0	No
Secondary	Deficit in protein S: yes/no		baseline (transversal); Day 0	No
Secondary	Excess of FVIII: yes/no	Excess of coagulation factor VIII?	baseline (transversal); Day 0	No
Secondary	Excess of homocystein? yes/no		baseline (transversal); Day 0	No
Secondary	presence/absence of allele F5 1691A	F5 1691A: allele 1691A for the factor V leiden gene	baseline (transversal); Day 0	No
Secondary	presence/absence of allele F2 20210A	F2 20210A: allele 20210A for the prothrombin gene	baseline (transversal); Day 0	No
Secondary	presence/absence of allele JAK2 617F	JAK2 617F: 617f mutation at the jak2 gene	baseline (transversal); Day 0	No
Secondary	Age at beginning of psychiatric symptoms	in years	baseline (transversal); Day 0	No
Secondary	Age at beginning of APL or thrombophilia symptoms	in years	baseline (transversal); Day 0	No