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Antiphospholipid SyndromeMENT-APL-ONCT01649479

Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

A study testing Antiphospholipid antibody tests, Thrombophilia bloodwork and Psychiatric evaluation in people with Antiphospholipid Syndrome, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Antiphospholipid Syndrome
What is being tested?
Antiphospholipid antibody tests, Thrombophilia bloodwork and Psychiatric evaluation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesFrance
Study dates
Apr 2013to Sep 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • APHM - Hôpital de la Conception

    Marseille, 13385

  • APHM - Hôpital La Timone Adultes

    Marseille, 13385

  • APHM - Hôpital Nord

    Marseille, 13915

  • CHU de Montpellier - Hôpital Saint-Eloi

    Montpellier, 34295

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

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:

  1. To compare the lifetime prevalence of these major disorders between groups;
  2. To assess the association of different, targeted, qualitative biomarkers with clinical symptomatology;
  3. To assess the association between the presence of "transitory APS" and the presence of psychiatric disorders;
  4. 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;
  5. Estimate the current prevalence (= the day of assessment) and intensity of major depressive episodes (MDE) in the sample of patients;
  6. Compare the prevalence of current MDE and the intensity of depressive symptoms present between groups;
  7. 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;
  8. 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;
  9. Compare the mean ages between groups;
  10. 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.
Being tested
Antiphospholipid antibody tests, Thrombophilia bloodwork, Psychiatric evaluation
Keywords
Obstetrical antiphospholipid syndrome, Thrombophilia
Medical subject headings
Antiphospholipid Syndrome, Thrombophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiphospholipid antibody testsBiological

    Each patient will be tested for antiphospholipid antibodies.

  • Thrombophilia bloodworkBiological

    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

  • Psychiatric evaluationOther

    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).

Study groups in NCT01649479
Study groupRoleWhat they receive
Suspected Obstetrical APS; confirmed APSOtherThe 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
Receives: Biological: Antiphospholipid antibody tests; Biological: Thrombophilia bloodwork; Other: Psychiatric evaluation
Sus. Obst. APS, confirmed thrombophiliaOtherThe 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
Receives: Biological: Antiphospholipid antibody tests; Biological: Thrombophilia bloodwork; Other: Psychiatric evaluation
Suspected Obstectrical APS; unconfirmedOtherThe 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
Receives: Biological: Antiphospholipid antibody tests; Biological: Thrombophilia bloodwork; Other: Psychiatric evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline (transversal); Day 0

Secondary outcomes (18)

  1. 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.

    Measured: baseline (transversal); Day 0

  2. SCID-1 score

    Structured Clinical Interview for Disorders (SCID-1) score for patients with a positive MINI evaluation.

    Measured: baseline (transversal); Day 0 or up to Day 15

  3. MDQ score

    Mood Disorder Questionnaire score

    Measured: baseline (transversal); Day 0

  4. BDI score

    The Beck Depression Inventory (BDI) score for currently depressed patients only.

    Measured: baseline (transversal); Day 0 or up to Day 15

  5. IDS-C score

    Inventory of Depressive Symptomatology (IDS-C) for currently depressed patients.

    Measured: baseline (transversal); Day 0 or up Day 15

  6. presence/absence of lupus anticoagulant

    Measured: baseline (transversal); Day 0

  7. presence/absence of anticardiolipid antibodies

    Measured: baseline (transversal); Day 0

  8. presence/absence of anti-beta2-glycoprotein 1 antibodies

    Measured: baseline (transversal); Day 0

  9. deficit in antithrombin: yes/no

    Measured: baseline (transversal); Day 0

  10. Deficit in protein C: yes/no

    Measured: baseline (transversal); Day 0

  11. Deficit in protein S: yes/no

    Measured: baseline (transversal); Day 0

  12. Excess of FVIII: yes/no

    Excess of coagulation factor VIII?

    Measured: baseline (transversal); Day 0

  13. Excess of homocystein? yes/no

    Measured: baseline (transversal); Day 0

  14. presence/absence of allele F5 1691A

    F5 1691A: allele 1691A for the factor V leiden gene

    Measured: baseline (transversal); Day 0

  15. presence/absence of allele F2 20210A

    F2 20210A: allele 20210A for the prothrombin gene

    Measured: baseline (transversal); Day 0

  16. presence/absence of allele JAK2 617F

    JAK2 617F: 617f mutation at the jak2 gene

    Measured: baseline (transversal); Day 0

  17. Age at beginning of psychiatric symptoms

    in years

    Measured: baseline (transversal); Day 0

  18. Age at beginning of APL or thrombophilia symptoms

    in years

    Measured: baseline (transversal); Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2012 (estimated)
  2. Study startApr 2013
  3. Primary completionSep 2013
  4. Study completionSep 2013

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01649479
Sponsor's protocol ID
PHRC-I/2012/FC-01
Other IDs
2012-A00705-38
Acronym
MENT-APL-O
Status last verified
Mar 2015
First submitted
23 Jul 2012
Last updated
25 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Antiphospholipid antibody tests, Thrombophilia bloodwork and Psychiatric evaluation in people with Antiphospholipid Syndrome, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Impossible to include patients at a correct rate; patients don't want to come back so they refuse participation.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

presence/absence of (lifetime) psychiatric symptoms (time frame: baseline (transversal); Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01649479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.

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