EpilepsyPRADOVNCT06829693
Evaluation of the Incidence of Psychiatric Disorders As a Function of First-line Antiepileptic Drug Prescribing Practices: Use of Assurance Maladie Databases
An observational study of Epilepsy and Side Effects of Drugs, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
An estimated 600,000 people suffer from epilepsy in France, with a prevalence of around 0.6%. The disease and its associated co-morbidities, particularly psychiatric, have a detrimental effect on the patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Side Effects of Drugs
- How many people
- 355,000 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2025to Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients benefiting from reimbursement by French health insurance for long-term antiepileptic treatment, and appearing in the health insurance reimbursement database.
Who may be able to join
- All adult patients (age ≥ 18 years), affiliated to the social security system with a first reimbursement of antiepileptic treatment
Who cannot join
- Patients with a psychiatric comorbidity, treated or not in the year preceding the index date of first prescription of the antiepileptic drug
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
An estimated 600,000 people suffer from epilepsy in France, with a prevalence of around 0.6%. The disease and its associated co-morbidities, particularly psychiatric, have a detrimental effect on the patient's quality of life. Recommendations for the management of epilepsy are based primarily on antiepileptic drug treatment. Therapeutic recommendations for this management have a limited level of evidence (usually grade C or expert agreement), with very few high-level evidence recommendations (grade A or B). In the first instance, monotherapy with progressive doses is recommended to avoid adverse effects at the start of treatment, notably sedation and dizziness.
Levetiracetam is one of the most widely prescribed antiepileptic drugs, thanks to its broad spectrum of antiepileptic activity and its reputedly favorable safety profile. In practice, however, this drug is associated with sometimes severe psychobehavioral side effects, including irritability and insomnia, as well as psychiatric side effects such as manic episodes, depressive episodes and suicidal crises. These psycho-behavioral and psychiatric episodes are described in the literature in cohorts of patients monitored in expert centers. In contrast, there are few published data on a population scale in primary care. Moreover, the risk factors for psychobehavioral and psychiatric episodes on levotetracetam are insufficiently known, and there are few data in terms of impact on the safety of the care pathway. In addition to the development of psychiatric comorbidities, potential negative impacts on the patient's care pathway include interruptions in anti-epileptic treatment with the risk of therapeutic failure, increased healthcare consumption and, ultimately, a deterioration in the patient's quality of life.
As these psychiatric side-effects are not well known to the majority of general practitioners, who are the main primary prescribers of antiepileptic drugs, we can hypothesize that there are many patients for whom these psychiatric disorders are not attributed to the antiepileptic treatment, and that the latter is not modified, negatively impacting the safety of the care pathway. It is for this reason that the latest HAS report of March 23, 2023 recommends that the initiation of the first treatment be carried out on the recommendation of a neurologist. The main objective is to estimate, among patients with no psychiatric history, the risk of developing psychiatric disorders in the year following initiation of 1st-line antiepileptic treatment, as a function of (i) the treatment prescribed in 1st line and (ii) the sequence of treatments, i.e. the sequence of different antiepileptic treatments. It is a retrospective cohort on medico-administrative databases. The inclusion period is January 1, 2016 - December 31, 2023 and all adult patients (age ≥ 18 years), affiliated to the social security system with a first reimbursement of antiepileptic treatment is included.
- Conditions
- Epilepsy, Side Effects of Drugs
- Keywords
- epilepsie, snds, bases de données médico-administratives
- Medical subject headings
- Epilepsy, Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of developing psychiatric disorders in the year following initiation of 1st-line antiepileptic treatment
Incidence of psychiatric disorders 1 year after initiation of antiepileptic treatment, defined as :
- Any hospitalization in MCO or RIM-P for psychiatric causes: ICD-10 codes F00 to F99 in DP or DR, except codes F70 to F79 (mental retardation) and F90 to F98 (behavioral and emotional disorders appearing during childhood and adolescence),
- Any consultation with a city psychiatrist or hospital psychiatrist (as part of an outpatient procedure),
- Any first prescription of a psychotropic drug: anxiolytics (ATC N05B*) - hypnotics (ATC N05C*) - antidepressants (ATC N06A*) - antipsychotics (ATC N05A*).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 355,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, GHU Paris Psychiatry & Neurosciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829693
- Sponsor's protocol ID
- APHP240983
- Other IDs
- PREPS 2024 - 983
- Acronym
- PRADOV
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: French law does not allow the sharing of data from the French insurance database.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of Psychiatric Disorders As a Function of First-line Antiepileptic Drug Prescribing Practices: Use of Assurance Maladie Databases
- ClinicalTrials.gov ID
- NCT06829693
- Acronym / sponsor ID
- PRADOV / APHP240983
- Conditions
- Epilepsy, Side Effects of Drugs
- Keywords
- epilepsie, snds, bases de données médico-administratives
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 355,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France, GHU Paris Psychiatry & Neurosciences
- Study start
- Feb 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (actual)
- 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.
An estimated 600,000 people suffer from epilepsy in France, with a prevalence of around 0.6%. The disease and its associated co-morbidities, particularly psychiatric, have a detrimental effect on the patient's quality of life. Recommendations for the management of epilepsy are based primarily on antiepileptic drug treatment. Therapeutic recommendations for this management have a limited level of evidence (usually grade C or expert agreement), with very few high-level evidence recommendations (grade A or B). In the first instance, monotherapy with progressive doses is recommended to avoid adverse effects at the start of treatment, notably sedation and dizziness.
Levetiracetam is one of the most widely prescribed antiepileptic drugs, thanks to its broad spectrum of antiepileptic activity and its reputedly favorable safety profile. In practice, however, this drug is associated with sometimes severe psychobehavioral side effects, including irritability and insomnia, as well as psychiatric side effects such as manic episodes, depressive episodes and suicidal crises. These psycho-behavioral and psychiatric episodes are described in the literature in cohorts of patients monitored in expert centers. In contrast, there are few published data on a population scale in primary care. Moreover, the risk factors for psychobehavioral and psychiatric episodes on levotetracetam are insufficiently known, and there are few data in terms of impact on the safety of the care pathway. In addition to the development of psychiatric comorbidities, potential negative impacts on the patient's care pathway include interruptions in anti-epileptic treatment with the risk of therapeutic failure, increased healthcare consumption and, ultimately, a deterioration in the patient's quality of life.
As these psychiatric side-effects are not well known to the majority of general practitioners, who are the main primary prescribers of antiepileptic drugs, we can hypothesize that there are many patients for whom these psychiatric disorders are not attributed to the antiepileptic treatment, and that the latter is not modified, negatively impacting the safety of the care pathway. It is for this reason that the latest HAS report of March 23, 2023 recommends that the initiation of the first treatment be carried out on the recommendation of a neurologist. The main objective is to estimate, among patients with no psychiatric history, the risk of developing psychiatric disorders in the year following initiation of 1st-line antiepileptic treatment, as a function of (i) the treatment prescribed in 1st line and (ii) the sequence of treatments, i.e. the sequence of different antiepileptic treatments. It is a retrospective cohort on medico-administrative databases. The inclusion period is January 1, 2016 - December 31, 2023 and all adult patients (age ≥ 18 years), affiliated to the social security system with a first reimbursement of antiepileptic treatment is included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients benefiting from reimbursement by French health insurance for long-term antiepileptic treatment, and appearing in the health insurance reimbursement database.
Key inclusion criteria (1 listed)
- All adult patients (age ≥ 18 years), affiliated to the social security system with a first reimbursement of antiepileptic treatment
Key exclusion criteria (1 listed)
- Patients with a psychiatric comorbidity, treated or not in the year preceding the index date of first prescription of the antiepileptic drug
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
risk of developing psychiatric disorders in the year following initiation of 1st-line antiepileptic treatment
Time frame: 12 months
Incidence of psychiatric disorders 1 year after initiation of antiepileptic treatment, defined as : * Any hospitalization in MCO or RIM-P for psychiatric causes: ICD-10 codes F00 to F99 in DP or DR, except codes F70 to F79 (mental retardation) and F90 to F98 (behavioral and emotional disorders appearing during childhood and adolescence), * Any consultation with a city psychiatrist or hospital psychiatrist (as part of an outpatient procedure), * Any first prescription of a psychotropic drug: anxiolytics (ATC N05B*) - hypnotics (ATC N05C*) - antidepressants (ATC N06A*) - antipsychotics (ATC N05A*).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No. French law does not allow the sharing of data from the French insurance database.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
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 Epilepsy and Side Effects of Drugs, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Célia Chatignoux (33156092000, celia.chatignoux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of developing psychiatric disorders in the year following initiation of 1st-line antiepileptic treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2025.