Clinical Trial: Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: July 23, 2012
Date Started: April 2013
Date Completion:
Last Updated: March 24, 2015
Last Verified: March 2015