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

This study has been terminated.
(Impossible to include patients at a correct rate; patients don't want to come back so they refuse participation.)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01649479
First received: July 23, 2012
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention
Antiphospholipid Syndrome
Biological: Antiphospholipid antibody tests
Biological: Thrombophilia bloodwork
Other: Psychiatric evaluation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • presence/absence of (lifetime) psychiatric symptoms [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (lifetime) psychiatric symptoms.


Secondary Outcome Measures:
  • presence/absence of (current) psychiatric symptoms [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (current) psychiatric symptoms.

  • SCID-1 score [ Time Frame: baseline (transversal); Day 0 or up to Day 15 ] [ Designated as safety issue: No ]
    Structured Clinical Interview for Disorders (SCID-1) score for patients with a positive MINI evaluation.

  • MDQ score [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Mood Disorder Questionnaire score

  • BDI score [ Time Frame: baseline (transversal); Day 0 or up to Day 15 ] [ Designated as safety issue: No ]
    The Beck Depression Inventory (BDI) score for currently depressed patients only.

  • IDS-C score [ Time Frame: baseline (transversal); Day 0 or up Day 15 ] [ Designated as safety issue: No ]
    Inventory of Depressive Symptomatology (IDS-C) for currently depressed patients.

  • presence/absence of lupus anticoagulant [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • presence/absence of anticardiolipid antibodies [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • presence/absence of anti-beta2-glycoprotein 1 antibodies [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • deficit in antithrombin: yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Deficit in protein C: yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Deficit in protein S: yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Excess of FVIII: yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Excess of coagulation factor VIII?

  • Excess of homocystein? yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • presence/absence of allele F5 1691A [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    F5 1691A: allele 1691A for the factor V leiden gene

  • presence/absence of allele F2 20210A [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    F2 20210A: allele 20210A for the prothrombin gene

  • presence/absence of allele JAK2 617F [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    JAK2 617F: 617f mutation at the jak2 gene

  • Age at beginning of psychiatric symptoms [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    in years

  • Age at beginning of APL or thrombophilia symptoms [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    in years


Enrollment: 20
Study Start Date: April 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: Antiphospholipid antibody tests
Each patient will be tested for antiphospholipid antibodies.
Biological: 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).
Other Name: Psychiatric evaluation
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
Biological: Antiphospholipid antibody tests
Each patient will be tested for antiphospholipid antibodies.
Biological: 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).
Other Name: Psychiatric evaluation
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
Biological: Antiphospholipid antibody tests
Each patient will be tested for antiphospholipid antibodies.
Biological: 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).
Other Name: Psychiatric evaluation

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649479

Locations
France
APHM - Hôpital Nord
Marseille Cedex 20, France, 13915
APHM - Hôpital de la Conception
Marseille Cedex 5, France, 13385
APHM - Hôpital La Timone Adultes
Marseille cedex 5, France, 13385
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, France, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01649479     History of Changes
Other Study ID Numbers: PHRC-I/2012/FC-01, 2012-A00705-38
Study First Received: July 23, 2012
Last Updated: August 8, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Obstetrical antiphospholipid syndrome
Thrombophilia

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Antiphospholipid
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014