TerminatedNCT01649479MENT-APL-OUpdated Mar 25, 2015

Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

An interventional study of Antiphospholipid antibody tests and Thrombophilia bloodwork in Antiphospholipid Syndrome, sponsored by Centre Hospitalier Universitaire de Nīmes. Terminated at 5 sites in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Basic science

Why this study was terminated

Impossible to include patients at a correct rate; patients don't want to come back so they refuse participation.

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Non-randomized
Ages: 18 Years to 45 Years
Sex: Female

Study 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).

Read the 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 studied

Antiphospholipid Syndrome

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Keywords

Obstetrical antiphospholipid syndrome
Thrombophilia

In context

Antiphospholipid Syndrome

121 studies on the registry are indexed under Antiphospholipid Syndrome; 51 are open to participants now.

This study's enrollment of 20 is below the median of 41 across 64 interventional studies indexed under Antiphospholipid Syndrome.

Browse Antiphospholipid Syndrome studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Single group
Masking: Single (Outcomes assessor)
Enrollment: 20 participants (actual)

Study arms

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: * antiphospholipid antibody tests * thrombophilia bloodwork * psychiatric evaluation
Biological: Antiphospholipid antibody tests · Biological: Thrombophilia bloodwork · Other: Psychiatric evaluation
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: * antiphospholipid antibody tests * thrombophilia bloodwork * psychiatric evaluation
Biological: Antiphospholipid antibody tests · Biological: Thrombophilia bloodwork · Other: Psychiatric evaluation
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: * antiphospholipid antibody tests * thrombophilia bloodwork * psychiatric evaluation
Biological: Antiphospholipid antibody tests · Biological: Thrombophilia bloodwork · Other: Psychiatric evaluation

Interventions

BiologicalAntiphospholipid antibody tests
Each patient will be tested for antiphospholipid antibodies.
BiologicalThrombophilia 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
OtherPsychiatric 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).

What researchers measure

Primary outcomes

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.
Time frame: baseline (transversal); Day 0

Secondary outcomes

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.
Time frame: baseline (transversal); Day 0
SCID-1 score
Structured Clinical Interview for Disorders (SCID-1) score for patients with a positive MINI evaluation.
Time frame: baseline (transversal); Day 0 or up to Day 15
MDQ score
Mood Disorder Questionnaire score
Time frame: baseline (transversal); Day 0
BDI score
The Beck Depression Inventory (BDI) score for currently depressed patients only.
Time frame: baseline (transversal); Day 0 or up to Day 15
IDS-C score
Inventory of Depressive Symptomatology (IDS-C) for currently depressed patients.
Time frame: baseline (transversal); Day 0 or up Day 15
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
Excess of coagulation factor VIII?
Time frame: baseline (transversal); Day 0
Excess of homocystein? yes/no
Time frame: baseline (transversal); Day 0
presence/absence of allele F5 1691A
F5 1691A: allele 1691A for the factor V leiden gene
Time frame: baseline (transversal); Day 0
presence/absence of allele F2 20210A
F2 20210A: allele 20210A for the prothrombin gene
Time frame: baseline (transversal); Day 0
presence/absence of allele JAK2 617F
JAK2 617F: 617f mutation at the jak2 gene
Time frame: baseline (transversal); Day 0
Age at beginning of psychiatric symptoms
in years
Time frame: baseline (transversal); Day 0
Age at beginning of APL or thrombophilia symptoms
in years
Time frame: baseline (transversal); Day 0

Study locations

5 sites

APHM - Hôpital Nord
Marseille Cedex 20, 13915, France
APHM - Hôpital de la Conception
Marseille Cedex 5, 13385, France
APHM - Hôpital La Timone Adultes
Marseille cedex 5, 13385, France
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, 34295, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, 30029, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01649479
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Responsible party: Sponsor
First posted: Jul 25, 2012
Start date: Apr 2013
Primary completion: Sep 2013
Completion: Sep 2013
Last update: Mar 25, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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