NCT01649479

Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Antiphospholipid Syndrome

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-07-25
• Last updated: 2015-03-25

Locations

5 sites across 1 country: France