Assessment of the Prevalence of Major Psychiatric Disorders in a Cohort of Women With Clinical Criteria Corresponding to Pure, Abortive-form, Obstetrical, Antiphospholipid Syndrome (NOHA-PSY)
|ClinicalTrials.gov Identifier: NCT02833194|
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
The primary objective of this study was to evaluate and compare the prevalence of the following psychiatric pathologies (based on the MINI5.0.0 questionnaire) among 3 groups of women (Leiden versus aP1Ab-positive versus thrombophilia-negative) with similar obstetrical histories 10 years after their initial assessment/diagnosis.
- Mood disorders, including depressive episodes during the previous two weeks, recurrent depressive disorders at any point in life, dysthymia in the last two years, or any current or past manic episode;
- Anxiety disorders, including current agoraphobia, current panic disorders, agoraphobia with panic disorders, current social phobia, generalized anxiety in the last 6 months, or current posttraumatic stress syndrome;
- Apparent psychotic syndromes, including isolated or recurrent psychotic syndromes, past or present (clinically validated),
- Current alcohol or drug problems (dependence or abuse).
|Condition or disease|
|Antiphospholipid Syndrome Factor V Leiden Thrombophilia|
|Study Type :||Observational|
|Actual Enrollment :||1592 participants|
|Official Title:||Assessment of the Prevalence of Major Psychiatric Disorders in a Cohort of Women With Clinical Criteria Corresponding to Pure, Abortive-form, Obstetrical, Antiphospholipid Syndrome|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Women with an isolated F5 rs6025 polymorphism or an isolated F2 rs1799963 polymorphism.
Inclusion in the "aP1Ab" Group:
Women with completely negative thombophilia screening results.
- Mini Internationl Neuropsychiatric Interview 5.0.0 [ Time Frame: 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833194
|CHU de Nîmes - Hôpital Universitaire Carémeau|
|Nîmes Cedex 09, France, 30029|
|Principal Investigator:||Jean-Christophe Gris, MD, PhD||Centre Hospitalier Universitaire de Nîmes|