## Protocol Section
### Identification Module
**NCT ID:** NCT01649479

**Acronym:** MENT-APL-O

**Brief Title:** Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

**Official Title:** Comparative Prevalence of Psychiatric Manifestations in Purely Obstetrical Antiphospholipid Syndrome

#### Organization Study ID Info
**ID:** PHRC-I/2012/FC-01
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nīmes
#### Secondary ID Infos
**Domain:** RCB number
**ID:** 2012-A00705-38
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2013-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-03-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-03-24

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2013-09

**Type:** ACTUAL

#### Start Date
**Date:** 2013-04

**Status Verified Date:** 2015-03

#### Study First Post Date
**Date:** 2012-07-25
**Type:** ESTIMATED
**Study First Submit Date:** 2012-07-23
**Study First Submit QC Date:** 2012-07-24
**Why Stopped:** Impossible to include patients at a correct rate; patients don't want to come back so they refuse participation.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Nīmes

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 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 Module

**Conditions:**

- Antiphospholipid Syndrome

**Keywords:**

- Obstetrical antiphospholipid syndrome

- Thrombophilia

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Biological: Antiphospholipid antibody tests

- Biological: Thrombophilia bloodwork

- Other: Psychiatric evaluation

**Label:** Suspected Obstetrical APS; confirmed APS

**Type:** OTHER

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Biological: Antiphospholipid antibody tests

- Biological: Thrombophilia bloodwork

- Other: Psychiatric evaluation

**Label:** Sus. Obst. APS, confirmed thrombophilia

**Type:** OTHER

#### Arm Group 3

**Description:** 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

**Intervention Names:**

- Biological: Antiphospholipid antibody tests

- Biological: Thrombophilia bloodwork

- Other: Psychiatric evaluation

**Label:** Suspected Obstectrical APS; unconfirmed

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sus. Obst. APS, confirmed thrombophilia

- Suspected Obstectrical APS; unconfirmed

- Suspected Obstetrical APS; confirmed APS

**Description:** Each patient will be tested for antiphospholipid antibodies.

**Name:** Antiphospholipid antibody tests

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Sus. Obst. APS, confirmed thrombophilia

- Suspected Obstectrical APS; unconfirmed

- Suspected Obstetrical APS; confirmed APS

**Description:** 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

**Name:** Thrombophilia bloodwork

**Type:** BIOLOGICAL

#### Intervention 3

**Arm Group Labels:**

- Sus. Obst. APS, confirmed thrombophilia

- Suspected Obstectrical APS; unconfirmed

- Suspected Obstetrical APS; confirmed APS

**Description:** 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).

**Name:** Psychiatric evaluation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (lifetime) psychiatric symptoms.

**Measure:** presence/absence of (lifetime) psychiatric symptoms

**Time Frame:** baseline (transversal); Day 0

#### Secondary Outcomes

**Description:** The Mini International Neuropsychiatric Interview (MINI 6) will be used to determined the presence/absence of (current) psychiatric symptoms.

**Measure:** presence/absence of (current) psychiatric symptoms

**Time Frame:** baseline (transversal); Day 0

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

**Measure:** SCID-1 score

**Time Frame:** baseline (transversal); Day 0 or up to Day 15

**Description:** Mood Disorder Questionnaire score

**Measure:** MDQ score

**Time Frame:** baseline (transversal); Day 0

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

**Measure:** BDI score

**Time Frame:** baseline (transversal); Day 0 or up to Day 15

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

**Measure:** IDS-C score

**Time Frame:** baseline (transversal); Day 0 or up Day 15

**Measure:** presence/absence of lupus anticoagulant

**Time Frame:** baseline (transversal); Day 0

**Measure:** presence/absence of anticardiolipid antibodies

**Time Frame:** baseline (transversal); Day 0

**Measure:** presence/absence of anti-beta2-glycoprotein 1 antibodies

**Time Frame:** baseline (transversal); Day 0

**Measure:** deficit in antithrombin: yes/no

**Time Frame:** baseline (transversal); Day 0

**Measure:** Deficit in protein C: yes/no

**Time Frame:** baseline (transversal); Day 0

**Measure:** Deficit in protein S: yes/no

**Time Frame:** baseline (transversal); Day 0

**Description:** Excess of coagulation factor VIII?

**Measure:** Excess of FVIII: yes/no

**Time Frame:** baseline (transversal); Day 0

**Measure:** Excess of homocystein? yes/no

**Time Frame:** baseline (transversal); Day 0

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

**Measure:** presence/absence of allele F5 1691A

**Time Frame:** baseline (transversal); Day 0

**Description:** F2 20210A: allele 20210A for the prothrombin gene

**Measure:** presence/absence of allele F2 20210A

**Time Frame:** baseline (transversal); Day 0

**Description:** JAK2 617F: 617f mutation at the jak2 gene

**Measure:** presence/absence of allele JAK2 617F

**Time Frame:** baseline (transversal); Day 0

**Description:** in years

**Measure:** Age at beginning of psychiatric symptoms

**Time Frame:** baseline (transversal); Day 0

**Description:** in years

**Measure:** Age at beginning of APL or thrombophilia symptoms

**Time Frame:** baseline (transversal); Day 0

### Eligibility Module

**Eligibility Criteria:** 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:

* 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

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Marseille Cedex 20

**Country:** France

**Facility:** APHM - Hôpital Nord

**Zip:** 13915

**Location 2:**

**City:** Marseille Cedex 5

**Country:** France

**Facility:** APHM - Hôpital de la Conception

**Zip:** 13385

**Location 3:**

**City:** Marseille cedex 5

**Country:** France

**Facility:** APHM - Hôpital La Timone Adultes

**Zip:** 13385

**Location 4:**

**City:** Montpellier

**Country:** France

**Facility:** CHU de Montpellier - Hôpital Saint-Eloi

**Zip:** 34295

**Location 5:**

**City:** Nîmes Cedex 09

**Country:** France

**Facility:** CHU de Nîmes - Hôpital Universitaire Carémeau

**Zip:** 30029

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M19097

- Name: Antiphospholipid Syndrome

- Relevance: HIGH

- As Found: Antiphospholipid Syndrome

- ID: M21737

- Name: Thrombophilia

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T438

- Name: Antiphospholipid Syndrome

- Relevance: HIGH

- As Found: Antiphospholipid Syndrome

### Condition Browse Module - Meshes

- ID: D000016736

- Term: Antiphospholipid Syndrome

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Coag

- Name: Coagulants

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: FiAg

- Name: Fibrinolytic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Program

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M16676

- Name: Thrombin

- Relevance: LOW

- As Found: Unknown

- ID: M4307

- Name: Antithrombins

- Relevance: LOW

- As Found: Unknown

- ID: M4306

- Name: Antithrombin III

- Relevance: LOW

- As Found: Unknown

- ID: M8312

- Name: Factor VIII

- Relevance: LOW

- As Found: Unknown

- ID: M19461

- Name: Antibodies, Antiphospholipid

- Relevance: HIGH

- As Found: 1.25 mg/ml

- ID: M14349

- Name: Protein C

- Relevance: LOW

- As Found: Unknown

- ID: M19587

- Name: Protein S

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000906

- Term: Antibodies

- ID: D000017152

- Term: Antibodies, Antiphospholipid

### Misc Info Module

- Version Holder: 2024-05-24
