Focal Epilepsy With and Without Secondary GeneralizationINSPEVNCT07471334
Prospective Study of Postictal Psychotic Symptoms Occuring After Video-EEG Monitoring in Focal Epilepsies
A study testing Psychiatric assessment in people with Focal Epilepsy With and Without Secondary Generalization and Psychotic Symptoms, run by Central Hospital, Nancy, France.
Trial summary
Psychotic disorders are up to eight times more prevalent in patients with epilepsy compared to the general population. Among them, postictal psychosis (PIP) is a severe complication of focal epilepsy, characterized by a brief psychotic episode emerging days after a seizure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Epilepsy With and Without Secondary Generalization, Psychotic Symptoms
- What is being tested?
- Psychiatric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- 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
Who may be able to join
- confirmed diagnosis of drug-resistant focal epilepsy
- hospitalization for at least 5 days video-EEG (or SEEG) monitoring
- capable of providing informed consent, able to communicate in French, and covered by a national health insurance plan
Who cannot join
- Patients presenting with psychotic symptoms at baseline (V1), or who have had recent modifications (less than 15 days before admission) to their antiepileptic or psychotropic medications, will be excluded to reduce confounding factors in the assessment of postictal psychotic symptoms.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Incidence of Postictal Psychotic Symptoms After a Video-EEG Monitoring : Impact of Focal Epileptic Seizures
Psychotic disorders are up to eight times more prevalent in patients with epilepsy compared to the general population. Among them, postictal psychosis (PIP) is a severe complication of focal epilepsy, characterized by a brief psychotic episode emerging days after a seizure. This project investigates a potentially attenuated and under-recognized manifestation-postictal psychotic symptoms (PPs)-that may arise following hospitalization in a video-EEG monitoring unit and might serve as an early indicator for future PIP.
The investigators hypothesize that the incidence of PPs is substantially higher than the 3% PIP prevalence reported in the literature and that their occurrence correlates with the intensity of epileptic activity triggered during video-EEG monitoring. The study has three main objectives: (1) to determine the incidence of PPs in patients with drug-resistant focal epilepsy, (2) to identify predictive factors associated with PPs, and (3) to assess the validity of the PQ-16 screening tool in this clinical context.
Read more
A prospective monocentric study will be conducted in the video-EEG unit of Nancy University Hospital. One hundred and ten patients hospitalized for at least five days will be included. Psychiatric assessments will include standardized clinical interviews, Brief Psychiatric Rating Scale (BPRS) scoring, and self-report questionnaires. These evaluations will take place at three timepoints: baseline (V1), 3-5 days post-discharge (V2), and two months post-discharge (V3).
This study aims to facilitate the early identification of PPs and support the development of preventive strategies, ultimately improving psychiatric care and overall management in patients with epilepsy.
Read the detailed description
The incidence of psychotic disorders during epilepsy is eight times higher than in the general population (Clancy et al., 2014). These disorders are classified according to their chronological link to seizures. A distinction is made between (1) peri-ictal disorders: occurring before, during, or after a seizure, and (2) interictal disorders: unrelated to the occurrence of a seizure. Among the peri-ictal disorders, postictal psychosis (PIP) constitutes a complication of epilepsy, marked by the sudden occurrence of a psychotic episode in the days following a seizure. During a PIP episode, delusional, hallucinatory, and manic symptoms are observed, often accompanied by significant agitation and, in some cases, violent behavior or self-harm. A study of 77 cases of PIP found that approximately one-third of the patients had committed a self- or other-directed act of aggression (Tarrada et al., 2022).
Other studies, all retrospective, have highlighted several risk factors for PIP, such as long-standing drug-resistant focal temporal epilepsy (typically evolving over 15 to 20 years), seizure clusters, bilateral tonic-clonic generalization of seizures, and the presence of independent bilateral epileptic anomalies. The estimated prevalence of PIP is approximately 2% to 4% according to current literature. This complication appears to be more common following video-EEG hospitalizations, during which seizures may be intentionally provoked for diagnostic purposes. PIP therefore represents a significant and potentially severe complication of both epilepsy and video-EEG, underscoring the need for early detection to mitigate its consequences.
Additionally, it is very likely that patients may experience psychotic symptoms (hallucinations, delusional thoughts) in a milder form during the days following video-EEG, which could be predictive of future PIP episodes. These subthreshold postictal psychotic symptoms (PPs) are currently poorly understood, especially among non-specialist psychiatrists and neurologists, contributing to their under-recognition and underdiagnosis-particularly when symptoms do not reach the threshold of a fully developed PIP.
The hypotheses to be verified are as follows: (1) The incidence of PPs is significantly higher (at least fourfold) than the prevalence of PIP (3%) reported in the literature. (2) The incidence of PPs increases proportionally with the number of seizures induced during video-EEG monitoring.
The investigators will conduct a prospective monocentric cohort study, based on regular psychiatric assessment and interventions, at the beginning of video-EEG hospitalization, and until 2 months after discharge.
- Being tested
- Psychiatric assessment
- Keywords
- postictal psychosis, epileptic psychoses, psychoses of epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric assessmentDiagnostic test
Description of the experimental design Data Collection and Visits
- Visit 0 (V0): Patient information and consent collection after eligibility screening.
- Visit 1 (V1): Psychiatric evaluation at the start of hospitalization, prior to any tapering of antiepileptic treatment. If psychotic symptoms are detected at this stage, the patient will be excluded from the study.
- Visit 2 (V2): Psychiatric assessment 3-5 days after discharge from video-EEG hospitalization. This timing is based on the average latency for PIP onset.
- Visit 3 (V3): Final evaluation two months after discharge, corresponding to the maximum observed latency for PIP.
Each visit includes:
- A semi-structured psychiatric clinical interview (adapted from the Mini International Neuropsychiatric Interview, M.I.N.I.)
- Clinician-rated assessment with the BPRS
- Self-report questionnaires: for depression, anxiety and psychosis
| Study group | Role | What they receive |
|---|---|---|
| Psychiatric prospective follow-up | Experimental | Not described Receives: Diagnostic Test: Psychiatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postictal psychotic symptoms
The percentage of patients presenting PPs after a video-EEG hospitalization. The diagnosis of PPs will be established based on a structured psychiatric clinical interview and the score obtained on the Brief Psychiatric Rating Scale (BPRS) (Adachi et al., 2024). This incidence will be compared with the 3% prevalence found in the literature. The BPRS is the reference scale in studies addressing psychotic symptoms in epilepsy and requires clinician scoring by a psychiatrist.
Measured: From enrollment until 2 months after video-EEG discharge
Secondary outcomes (2)
Risk factors associated with the occurrence of psychotic symptoms following video-EEG
Risk factors will be assessed based on variables related to the video-EEG hospitalization (e.g., number and type of seizures, presence of subclinical seizures, drug withdrawal), characteristics of epilepsy (type, focus, duration, seizure frequency, treatments), and psychiatric history or comorbidities.
Measured: From enrollment until 2 months after video-EEG discharge
Psychometric properties and diagnostic performance of the Prodromal Questionnaire-16 (PQ-16)
Psychometric validation of the PQ-16 will involve assessing internal consistency, structural validity, and diagnostic performance. Analyses will identify an optimal cut-off score and calculate sensitivity, specificity, and positive and negative predictive values. The gold standard will be the diagnosis of PPs based on a psychiatric clinical interview and BPRS scoring.
Measured: From enrollment until 2 months after video-EEG discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start29 Sep 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Focal Epilepsy With and Without Secondary GeneralizationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TARRADA Alexis, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471334
- Sponsor's protocol ID
- 2024PI259
- Acronym
- INSPEV
- Status last verified
- May 2026
- First submitted
- 10 Mar 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tarrada A, Hingray C, Aron O, Dupont S, Maillard L, de Toffol B. Postictal psychosis, a cause of secondary affective psychosis: A clinical description study of 77 patients. Epilepsy Behav. 2022 Feb;127:108553. doi: 10.1016/j.yebeh.2022.108553. Epub 2022 Jan 21.
PubMed 35074723Tarrada A, Hingray C, Sachdev P, Le Thien MA, Kanemoto K, de Toffol B. Epileptic psychoses are underrecognized by French neurologists and psychiatrists. Epilepsy Behav. 2019 Nov;100(Pt A):106528. doi: 10.1016/j.yebeh.2019.106528. Epub 2019 Oct 24.
PubMed 31654941Shen S, Sun H, Dong Z, Yi T, Sander JW, Zhou D, Li J. Prevalence, clinical characteristics, and risk factors for psychosis in people with epilepsy: A multicenter retrospective cohort study. Epilepsia. 2025 Aug;66(8):2904-2915. doi: 10.1111/epi.18409. Epub 2025 Apr 23.
PubMed 40266083Grau-Lopez L, Jimenez M, Ciurans J, Gea M, Fumanal A, Caceres C, Garcia-Armengol R, Becerra JL. Clinical predictors of adverse events during continuous video-EEG monitoring in an epilepsy unit. Epileptic Disord. 2020 Aug 1;22(4):449-454. doi: 10.1684/epd.2020.1177.
PubMed 32723705
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postictal Psychotic Symptoms After a Video-EEG Monitoring : Impact of Focal Epileptic Seizures
- ClinicalTrials.gov ID
- NCT07471334
- Acronym / sponsor ID
- INSPEV / 2024PI259
- Keywords
- postictal psychosis, epileptic psychoses, psychoses of epilepsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 29 Sep 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 13 Mar 2026 (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.
Psychotic disorders are up to eight times more prevalent in patients with epilepsy compared to the general population. Among them, postictal psychosis (PIP) is a severe complication of focal epilepsy, characterized by a brief psychotic episode emerging days after a seizure. This project investigates a potentially attenuated and under-recognized manifestation-postictal psychotic symptoms (PPs)-that may arise following hospitalization in a video-EEG monitoring unit and might serve as an early indicator for future PIP.
The investigators hypothesize that the incidence of PPs is substantially higher than the 3% PIP prevalence reported in the literature and that their occurrence correlates with the intensity of epileptic activity triggered during video-EEG monitoring. The study has three main objectives: (1) to determine the incidence of PPs in patients with drug-resistant focal epilepsy, (2) to identify predictive factors associated with PPs, and (3) to assess the validity of the PQ-16 screening tool in this clinical context.
A prospective monocentric study will be conducted in the video-EEG unit of Nancy University Hospital. One hundred and ten patients hospitalized for at least five days will be included. Psychiatric assessments will include standardized clinical interviews, Brief Psychiatric Rating Scale (BPRS) scoring, and self-report questionnaires. These evaluations will take place at three timepoints: baseline (V1), 3-5 days post-discharge (V2), and two months post-discharge (V3).
This study aims to facilitate the early identification of PPs and support the development of preventive strategies, ultimately improving psychiatric care and overall management in patients with epilepsy.
Detailed description
The incidence of psychotic disorders during epilepsy is eight times higher than in the general population (Clancy et al., 2014). These disorders are classified according to their chronological link to seizures. A distinction is made between (1) peri-ictal disorders: occurring before, during, or after a seizure, and (2) interictal disorders: unrelated to the occurrence of a seizure. Among the peri-ictal disorders, postictal psychosis (PIP) constitutes a complication of epilepsy, marked by the sudden occurrence of a psychotic episode in the days following a seizure. During a PIP episode, delusional, hallucinatory, and manic symptoms are observed, often accompanied by significant agitation and, in some cases, violent behavior or self-harm. A study of 77 cases of PIP found that approximately one-third of the patients had committed a self- or other-directed act of aggression (Tarrada et al., 2022).
Other studies, all retrospective, have highlighted several risk factors for PIP, such as long-standing drug-resistant focal temporal epilepsy (typically evolving over 15 to 20 years), seizure clusters, bilateral tonic-clonic generalization of seizures, and the presence of independent bilateral epileptic anomalies. The estimated prevalence of PIP is approximately 2% to 4% according to current literature. This complication appears to be more common following video-EEG hospitalizations, during which seizures may be intentionally provoked for diagnostic purposes. PIP therefore represents a significant and potentially severe complication of both epilepsy and video-EEG, underscoring the need for early detection to mitigate its consequences.
Additionally, it is very likely that patients may experience psychotic symptoms (hallucinations, delusional thoughts) in a milder form during the days following video-EEG, which could be predictive of future PIP episodes. These subthreshold postictal psychotic symptoms (PPs) are currently poorly understood, especially among non-specialist psychiatrists and neurologists, contributing to their under-recognition and underdiagnosis-particularly when symptoms do not reach the threshold of a fully developed PIP.
The hypotheses to be verified are as follows: (1) The incidence of PPs is significantly higher (at least fourfold) than the prevalence of PIP (3%) reported in the literature. (2) The incidence of PPs increases proportionally with the number of seizures induced during video-EEG monitoring.
The investigators will conduct a prospective monocentric cohort study, based on regular psychiatric assessment and interventions, at the beginning of video-EEG hospitalization, and until 2 months after discharge.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychiatric prospective follow-up | Experimental | Diagnostic Test: Psychiatric assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed diagnosis of drug-resistant focal epilepsy
- hospitalization for at least 5 days video-EEG (or SEEG) monitoring
- capable of providing informed consent, able to communicate in French, and covered by a national health insurance plan
Key exclusion criteria (1 listed)
- Patients presenting with psychotic symptoms at baseline (V1), or who have had recent modifications (less than 15 days before admission) to their antiepileptic or psychotropic medications, will be excluded to reduce confounding factors in the assessment of postictal psychotic symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric assessmentDescription of the experimental design Data Collection and Visits 1. Visit 0 (V0): Patient information and consent collection after eligibility screening. 2. Visit 1 (V1): Psychiatric evaluation at the start of hospitalization, prior to any tapering of antiepileptic treatment. If psychotic symptoms are detected at this stage, the patient will be excluded from the study. 3. Visit 2 (V2): Psychiatric assessment 3-5 days after discharge from video-EEG hospitalization. This timing is based on the average latency for PIP onset. 4. Visit 3 (V3): Final evaluation two months after discharge, corresponding to the maximum observed latency for PIP. Each visit includes: * A semi-structured psychiatric clinical interview (adapted from the Mini International Neuropsychiatric Interview, M.I.N.I.) * Clinician-rated assessment with the BPRS * Self-report questionnaires: for depression, anxiety and psychosis | Diagnostic test | Psychiatric prospective follow-up |
Primary outcome
Incidence of postictal psychotic symptoms
Time frame: From enrollment until 2 months after video-EEG discharge
The percentage of patients presenting PPs after a video-EEG hospitalization. The diagnosis of PPs will be established based on a structured psychiatric clinical interview and the score obtained on the Brief Psychiatric Rating Scale (BPRS) (Adachi et al., 2024). This incidence will be compared with the 3% prevalence found in the literature. The BPRS is the reference scale in studies addressing psychotic symptoms in epilepsy and requires clinician scoring by a psychiatrist.
2 secondary outcomes
Risk factors associated with the occurrence of psychotic symptoms following video-EEG
Time frame: From enrollment until 2 months after video-EEG discharge
Psychometric properties and diagnostic performance of the Prodromal Questionnaire-16 (PQ-16)
Time frame: From enrollment until 2 months after video-EEG discharge
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 24 Sep 2026.
- Background: PubMed 35074723Tarrada A, Hingray C, Aron O, Dupont S, Maillard L, de Toffol B. Postictal psychosis, a cause of secondary affective psychosis: A clinical description study of 77 patients. Epilepsy Behav. 2022 Feb;127:108553. doi: 10.1016/j.yebeh.2022.108553. Epub 2022 Jan 21.
- Background: PubMed 31654941Tarrada A, Hingray C, Sachdev P, Le Thien MA, Kanemoto K, de Toffol B. Epileptic psychoses are underrecognized by French neurologists and psychiatrists. Epilepsy Behav. 2019 Nov;100(Pt A):106528. doi: 10.1016/j.yebeh.2019.106528. Epub 2019 Oct 24.
- Background: PubMed 40266083Shen S, Sun H, Dong Z, Yi T, Sander JW, Zhou D, Li J. Prevalence, clinical characteristics, and risk factors for psychosis in people with epilepsy: A multicenter retrospective cohort study. Epilepsia. 2025 Aug;66(8):2904-2915. doi: 10.1111/epi.18409. Epub 2025 Apr 23.
- Background: PubMed 32723705Grau-Lopez L, Jimenez M, Ciurans J, Gea M, Fumanal A, Caceres C, Garcia-Armengol R, Becerra JL. Clinical predictors of adverse events during continuous video-EEG monitoring in an epilepsy unit. Epileptic Disord. 2020 Aug 1;22(4):449-454. doi: 10.1684/epd.2020.1177.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric assessment in people with Focal Epilepsy With and Without Secondary Generalization and Psychotic Symptoms, run by Central Hospital, Nancy, 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 3 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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Alexis Tarrada, MD (+33383852457, a.tarrada@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postictal psychotic symptoms (time frame: From enrollment until 2 months after video-EEG discharge). 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 NCT07471334, which also lists 4 linked publications.
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 24 Sep 2026.