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

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ClinicalTrials.gov Identifier: NCT01649479
Recruitment Status : Terminated (Impossible to include patients at a correct rate; patients don't want to come back so they refuse participation.)
First Posted : July 25, 2012
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date  ICMJE July 23, 2012
First Posted Date  ICMJE July 25, 2012
Last Update Posted Date March 25, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01649479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2012)
  • 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.
  • 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.
  • MDQ score [ Time Frame: baseline (transversal); Day 0 ]
    Mood Disorder Questionnaire score
  • BDI score [ Time Frame: baseline (transversal); Day 0 or up to Day 15 ]
    The Beck Depression Inventory (BDI) score for currently depressed patients only.
  • IDS-C score [ Time Frame: baseline (transversal); Day 0 or up Day 15 ]
    Inventory of Depressive Symptomatology (IDS-C) for currently depressed patients.
  • presence/absence of lupus anticoagulant [ Time Frame: baseline (transversal); Day 0 ]
  • presence/absence of anticardiolipid antibodies [ Time Frame: baseline (transversal); Day 0 ]
  • 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 [ Time Frame: baseline (transversal); Day 0 ]
    Excess of coagulation factor VIII?
  • Excess of homocystein? yes/no [ Time Frame: 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
  • presence/absence of allele F2 20210A [ Time Frame: baseline (transversal); Day 0 ]
    F2 20210A: allele 20210A for the prothrombin gene
  • presence/absence of allele JAK2 617F [ Time Frame: baseline (transversal); Day 0 ]
    JAK2 617F: 617f mutation at the jak2 gene
  • Age at beginning of psychiatric symptoms [ Time Frame: baseline (transversal); Day 0 ]
    in years
  • Age at beginning of APL or thrombophilia symptoms [ Time Frame: baseline (transversal); Day 0 ]
    in years
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome
Official Title  ICMJE Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Antiphospholipid Syndrome
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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
    Interventions:
    • Biological: Antiphospholipid antibody tests
    • Biological: Thrombophilia bloodwork
    • Other: 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
    Interventions:
    • Biological: Antiphospholipid antibody tests
    • Biological: Thrombophilia bloodwork
    • Other: 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
    Interventions:
    • Biological: Antiphospholipid antibody tests
    • Biological: Thrombophilia bloodwork
    • Other: Psychiatric evaluation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 7, 2014)
20
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2012)
1000
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01649479
Other Study ID Numbers  ICMJE PHRC-I/2012/FC-01
2012-A00705-38 ( Other Identifier: RCB number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nīmes
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP