An interventional study of Psychiatric assessment in Focal Epilepsy With and Without Secondary Generalization and Psychotic Symptoms, sponsored by Central Hospital, Nancy, France. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Screening
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.
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.
243 studies on the registry are indexed under Epilepsies, Partial; 49 are open to participants now.
This study's planned enrollment of 110 is above the median of 90 across 187 interventional studies indexed under Epilepsies, Partial.
Browse Epilepsies, Partial studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Psychiatric assessment
Description 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
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.
Time frame: From enrollment until 2 months after video-EEG discharge
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.
Time frame: 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.
Time frame: From enrollment until 2 months after video-EEG discharge
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Plan to share: Undecided
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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