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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00705-38 | Other Identifier | RCB number |
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Impossible to include patients at a correct rate; patients don't want to come back so they refuse participation.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected Obstetrical APS; confirmed APS | Other | 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:
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| Sus. Obst. APS, confirmed thrombophilia | Other | 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:
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| Suspected Obstectrical APS; unconfirmed | Other | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiphospholipid antibody tests | Biological | Each patient will be tested for antiphospholipid antibodies. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| SCID-1 score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHM - Hôpital de la Conception | Marseille | 13385 | France | |||
| APHM - Hôpital La Timone Adultes |
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| Thrombophilia bloodwork | Biological | Bloodwork will be drawn up for:
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| Psychiatric evaluation | Other | 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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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 | Mood Disorder Questionnaire score | baseline (transversal); Day 0 |
| BDI score | The Beck Depression Inventory (BDI) score for currently depressed patients only. | baseline (transversal); Day 0 or up to Day 15 |
| IDS-C score | Inventory of Depressive Symptomatology (IDS-C) for currently depressed patients. | baseline (transversal); Day 0 or up Day 15 |
| presence/absence of lupus anticoagulant | baseline (transversal); Day 0 |
| presence/absence of anticardiolipid antibodies | baseline (transversal); Day 0 |
| presence/absence of anti-beta2-glycoprotein 1 antibodies | baseline (transversal); Day 0 |
| deficit in antithrombin: yes/no | baseline (transversal); Day 0 |
| Deficit in protein C: yes/no | baseline (transversal); Day 0 |
| Deficit in protein S: yes/no | baseline (transversal); Day 0 |
| Excess of FVIII: yes/no | Excess of coagulation factor VIII? | baseline (transversal); Day 0 |
| Excess of homocystein? yes/no | baseline (transversal); Day 0 |
| presence/absence of allele F5 1691A | F5 1691A: allele 1691A for the factor V leiden gene | baseline (transversal); Day 0 |
| presence/absence of allele F2 20210A | F2 20210A: allele 20210A for the prothrombin gene | baseline (transversal); Day 0 |
| presence/absence of allele JAK2 617F | JAK2 617F: 617f mutation at the jak2 gene | baseline (transversal); Day 0 |
| Age at beginning of psychiatric symptoms | in years | baseline (transversal); Day 0 |
| Age at beginning of APL or thrombophilia symptoms | in years | baseline (transversal); Day 0 |
| Marseille |
| 13385 |
| France |
| APHM - Hôpital Nord | Marseille | 13915 | France |
| CHU de Montpellier - Hôpital Saint-Eloi | Montpellier | 34295 | France |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| ID | Term |
|---|---|
| D016736 | Antiphospholipid Syndrome |
| D019851 | Thrombophilia |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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