Antiphospholipid SyndromeNOHA-PSYNCT02833194
Assessment of the Prevalence of Major Psychiatric Disorders in a Cohort of Women With Clinical Criteria Corresponding to Pure, Abortive-form, Obstetrical, Antiphospholipid Syndrome
An observational study of Antiphospholipid Syndrome and Factor V Leiden Thrombophilia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Antiphospholipid Syndrome, Factor V Leiden Thrombophilia
- How many people
- 1,592 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2005to 31 Dec 2018
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients were selected via the regional NOHA (Nîmes Obstetricians and Hematologists - Antiphospholipid Syndrome study) network, which referred women with losses of spontaneous pregnancies to the Hematology Outpatient Department of the Nîmes University Hospital.
Who may be able to join
- Three unexplained consecutive spontaneous abortions before the 10th week of gestation (the recurrent embryo loss subgroup) - OR -
- One unexplained death of a morphologically normal fetus (fetal loss) at or after the 10th week of gestation (fetal loss subgroup).
Who cannot join
- Any history of thrombotic events or any treatment given during previous pregnancies that might have modified the natural course of the condition
- Women whose pregnancy losses could be explained by infectious, metabolic, anatomic or hormonal facotrs, or associated with paternal or maternal chromosomal causes
- Seropositivity for HIV, hepatitis B or C
- Women with antithrombin, protein C, or protein S deficiency, and women with abnormal fibrinogen or with the JAK2 V617F mutation were further excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Medical subject headings
- Antiphospholipid Syndrome, Thrombophilia due to Activated Protein C Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Leiden Group | Women with an isolated F5 rs6025 polymorphism or an isolated F2 rs1799963 polymorphism. | |
| aP1Ab-positive | Inclusion in the "aP1Ab" Group: * Initially positive for aP1Ab * Second positive aP1Ab test six months later | |
| Thrombophilia-negative | Women with completely negative thombophilia screening results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Internationl Neuropsychiatric Interview 5.0.0
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2005
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe Gris, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833194
- Sponsor's protocol ID
- LOCAL/2015/JCG-01
- Acronym
- NOHA-PSY
- Status last verified
- Jun 2023
- First submitted
- 12 Jul 2016
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Gris JC, Cyprien F, Bouvier S, Cochery-Nouvellon E, Lavigne-Lissalde G, Mercier E, Balducchi JP. Antiphospholipid antibodies are associated with positive screening for common mental disorders in women with previous pregnancy loss. The NOHA-PSY observational study. World J Biol Psychiatry. 2019 Jan;20(1):51-63. doi: 10.1080/15622975.2017.1333146. Epub 2017 Jun 19.
PubMed 28532221
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02833194
- Acronym / sponsor ID
- NOHA-PSY / LOCAL/2015/JCG-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,592 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leiden Group | – | –Women with an isolated F5 rs6025 polymorphism or an isolated F2 rs1799963 polymorphism. |
| aP1Ab-positive | – | –Inclusion in the "aP1Ab" Group: * Initially positive for aP1Ab * Second positive aP1Ab test six months later |
| Thrombophilia-negative | – | –Women with completely negative thombophilia screening results. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were selected via the regional NOHA (Nîmes Obstetricians and Hematologists - Antiphospholipid Syndrome study) network, which referred women with losses of spontaneous pregnancies to the Hematology Outpatient Department of the Nîmes University Hospital.
Key inclusion criteria (2 listed)
- Three unexplained consecutive spontaneous abortions before the 10th week of gestation (the recurrent embryo loss subgroup) - OR -
- One unexplained death of a morphologically normal fetus (fetal loss) at or after the 10th week of gestation (fetal loss subgroup).
Key exclusion criteria (4 listed)
- Any history of thrombotic events or any treatment given during previous pregnancies that might have modified the natural course of the condition
- Women whose pregnancy losses could be explained by infectious, metabolic, anatomic or hormonal facotrs, or associated with paternal or maternal chromosomal causes
- Seropositivity for HIV, hepatitis B or C
- Women with antithrombin, protein C, or protein S deficiency, and women with abnormal fibrinogen or with the JAK2 V617F mutation were further excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini Internationl Neuropsychiatric Interview 5.0.0
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 28532221Gris JC, Cyprien F, Bouvier S, Cochery-Nouvellon E, Lavigne-Lissalde G, Mercier E, Balducchi JP. Antiphospholipid antibodies are associated with positive screening for common mental disorders in women with previous pregnancy loss. The NOHA-PSY observational study. World J Biol Psychiatry. 2019 Jan;20(1):51-63. doi: 10.1080/15622975.2017.1333146. Epub 2017 Jun 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christophe Gris, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome and Factor V Leiden Thrombophilia, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mini Internationl Neuropsychiatric Interview 5.0.0 (time frame: 10 years). 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 NCT02833194, which also lists 1 linked publication.
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 21 Nov 2025.