Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome (MENT-APL-O)

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).

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Marseille Cedex 20, France, 13915
        • Aphm - Hopital Nord
      • Marseille Cedex 5, France, 13385
        • APHM - Hôpital de la Conception
      • Marseille cedex 5, France, 13385
        • APHM - Hôpital La Timone Adultes
      • Montpellier, France, 34295
        • CHU de Montpellier - Hopital Saint-Eloi
      • Nîmes Cedex 09, France, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Suspected Obstetrical APS; confirmed APS

The patients included in this study are women actively addressed to the participating departments because of clinical symptoms corresponding to suspected obstetrical anti-phospholipid syndrome.

Bloodwork later confirms that these patients have APS.

All patients included in this study will have the following interventions:

  • antiphospholipid antibody tests
  • thrombophilia bloodwork
  • psychiatric evaluation
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).
Other: Sus. Obst. APS, confirmed thrombophilia

The patients included in this study are women actively addressed to the participating departments because of clinical symptoms corresponding to suspected obstetrical anti-phospholipid syndrome.

Bloodwork later confirms that these patients are thrombophilic.

All patients included in this study will have the following interventions:

  • antiphospholipid antibody tests
  • thrombophilia bloodwork
  • psychiatric evaluation
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).
Other: Suspected Obstectrical APS; unconfirmed

The patients included in this study are women actively addressed to the participating departments because of clinical symptoms corresponding to suspected obstetrical anti-phospholipid syndrome.

Bloodwork cannot confirm APS, nor thrombophilia.

All patients included in this study will have the following interventions:

  • antiphospholipid antibody tests
  • thrombophilia bloodwork
  • psychiatric evaluation
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence/absence of (lifetime) psychiatric symptoms
Time Frame: baseline (transversal); Day 0
The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (lifetime) psychiatric symptoms.
baseline (transversal); Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence/absence of (current) psychiatric symptoms
Time Frame: baseline (transversal); Day 0
The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (current) psychiatric symptoms.
baseline (transversal); Day 0
SCID-1 score
Time Frame: baseline (transversal); Day 0 or up to Day 15
Structured Clinical Interview for Disorders (SCID-1) score for patients with a positive MINI evaluation.
baseline (transversal); Day 0 or up to Day 15
MDQ score
Time Frame: baseline (transversal); Day 0
Mood Disorder Questionnaire score
baseline (transversal); Day 0
BDI score
Time Frame: baseline (transversal); Day 0 or up to Day 15
The Beck Depression Inventory (BDI) score for currently depressed patients only.
baseline (transversal); Day 0 or up to Day 15
IDS-C score
Time Frame: baseline (transversal); Day 0 or up Day 15
Inventory of Depressive Symptomatology (IDS-C) for currently depressed patients.
baseline (transversal); Day 0 or up Day 15
presence/absence of lupus anticoagulant
Time Frame: baseline (transversal); Day 0
baseline (transversal); Day 0
presence/absence of anticardiolipid antibodies
Time Frame: baseline (transversal); Day 0
baseline (transversal); Day 0
presence/absence of anti-beta2-glycoprotein 1 antibodies
Time Frame: baseline (transversal); Day 0
baseline (transversal); Day 0
deficit in antithrombin: yes/no
Time Frame: baseline (transversal); Day 0
baseline (transversal); Day 0
Deficit in protein C: yes/no
Time Frame: baseline (transversal); Day 0
baseline (transversal); Day 0
Deficit in protein S: yes/no
Time Frame: baseline (transversal); Day 0
baseline (transversal); Day 0
Excess of FVIII: yes/no
Time Frame: baseline (transversal); Day 0
Excess of coagulation factor VIII?
baseline (transversal); Day 0
Excess of homocystein? yes/no
Time Frame: baseline (transversal); Day 0
baseline (transversal); Day 0
presence/absence of allele F5 1691A
Time Frame: baseline (transversal); Day 0
F5 1691A: allele 1691A for the factor V leiden gene
baseline (transversal); Day 0
presence/absence of allele F2 20210A
Time Frame: baseline (transversal); Day 0
F2 20210A: allele 20210A for the prothrombin gene
baseline (transversal); Day 0
presence/absence of allele JAK2 617F
Time Frame: baseline (transversal); Day 0
JAK2 617F: 617f mutation at the jak2 gene
baseline (transversal); Day 0
Age at beginning of psychiatric symptoms
Time Frame: baseline (transversal); Day 0
in years
baseline (transversal); Day 0
Age at beginning of APL or thrombophilia symptoms
Time Frame: baseline (transversal); Day 0
in years
baseline (transversal); Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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