- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01649479
Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome (MENT-APL-O)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Marseille Cedex 20, France, 13915
- Aphm - Hopital Nord
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Marseille Cedex 5, France, 13385
- APHM - Hôpital de la Conception
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Marseille cedex 5, France, 13385
- APHM - Hôpital La Timone Adultes
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Montpellier, France, 34295
- CHU de Montpellier - Hopital Saint-Eloi
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Nîmes Cedex 09, France, 30029
- CHU de Nimes - Hopital Universitaire Caremeau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Each patient will be tested for antiphospholipid antibodies.
Bloodwork will be drawn up for:
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).
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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:
|
Each patient will be tested for antiphospholipid antibodies.
Bloodwork will be drawn up for:
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).
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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:
|
Each patient will be tested for antiphospholipid antibodies.
Bloodwork will be drawn up for:
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).
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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
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The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (lifetime) psychiatric symptoms.
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baseline (transversal); Day 0
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
presence/absence of (current) psychiatric symptoms
Time Frame: baseline (transversal); Day 0
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The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (current) psychiatric symptoms.
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baseline (transversal); Day 0
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SCID-1 score
Time Frame: baseline (transversal); Day 0 or up to Day 15
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Structured Clinical Interview for Disorders (SCID-1) score for patients with a positive MINI evaluation.
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baseline (transversal); Day 0 or up to Day 15
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MDQ score
Time Frame: baseline (transversal); Day 0
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Mood Disorder Questionnaire score
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baseline (transversal); Day 0
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BDI score
Time Frame: baseline (transversal); Day 0 or up to Day 15
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The Beck Depression Inventory (BDI) score for currently depressed patients only.
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baseline (transversal); Day 0 or up to Day 15
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IDS-C score
Time Frame: baseline (transversal); Day 0 or up Day 15
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Inventory of Depressive Symptomatology (IDS-C) for currently depressed patients.
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baseline (transversal); Day 0 or up Day 15
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presence/absence of lupus anticoagulant
Time Frame: baseline (transversal); Day 0
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baseline (transversal); Day 0
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presence/absence of anticardiolipid antibodies
Time Frame: baseline (transversal); Day 0
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baseline (transversal); Day 0
|
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presence/absence of anti-beta2-glycoprotein 1 antibodies
Time Frame: baseline (transversal); Day 0
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baseline (transversal); Day 0
|
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deficit in antithrombin: yes/no
Time Frame: baseline (transversal); Day 0
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baseline (transversal); Day 0
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Deficit in protein C: yes/no
Time Frame: baseline (transversal); Day 0
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baseline (transversal); Day 0
|
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Deficit in protein S: yes/no
Time Frame: baseline (transversal); Day 0
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baseline (transversal); Day 0
|
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Excess of FVIII: yes/no
Time Frame: baseline (transversal); Day 0
|
Excess of coagulation factor VIII?
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baseline (transversal); Day 0
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Excess of homocystein? yes/no
Time Frame: baseline (transversal); Day 0
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baseline (transversal); Day 0
|
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presence/absence of allele F5 1691A
Time Frame: baseline (transversal); Day 0
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F5 1691A: allele 1691A for the factor V leiden gene
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baseline (transversal); Day 0
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presence/absence of allele F2 20210A
Time Frame: baseline (transversal); Day 0
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F2 20210A: allele 20210A for the prothrombin gene
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baseline (transversal); Day 0
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presence/absence of allele JAK2 617F
Time Frame: baseline (transversal); Day 0
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JAK2 617F: 617f mutation at the jak2 gene
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baseline (transversal); Day 0
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Age at beginning of psychiatric symptoms
Time Frame: baseline (transversal); Day 0
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in years
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baseline (transversal); Day 0
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Age at beginning of APL or thrombophilia symptoms
Time Frame: baseline (transversal); Day 0
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in years
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baseline (transversal); Day 0
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRC-I/2012/FC-01
- 2012-A00705-38 (Other Identifier: RCB number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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