Prospective Study of Postictal Psychotic Symptoms Occuring After Video-EEG Monitoring in Focal Epilepsies

NCT07471334 | Not Yet Recruiting

• 1 other identifier: 2024PI259
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Focal Epilepsy With and Without Secondary Generalization; Psychotic Symptoms

Keywords

postictal psychosis; epileptic psychoses; psychoses of epilepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment until 2 months after video-EEG discharge

Secondary Outcomes (2)

• Risk factors associated with the occurrence of psychotic symptoms following video-EEG

  From enrollment until 2 months after video-EEG discharge

• Psychometric properties and diagnostic performance of the Prodromal Questionnaire-16 (PQ-16)

  From enrollment until 2 months after video-EEG discharge

Study Arms (1)

Psychiatric prospective follow-up

EXPERIMENTAL

Diagnostic Test: Psychiatric assessment

Interventions

Psychiatric assessment DIAGNOSTIC_TEST

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

Psychiatric prospective follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (4)

• 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.

  PMID: 35074723 BACKGROUND

• Tarrada 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.

  PMID: 31654941 BACKGROUND

• Shen 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.

  PMID: 40266083 BACKGROUND

• Grau-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.

  PMID: 32723705 BACKGROUND

Central Study Contacts

Alexis Tarrada, MD

CONTACT

+33383852457; a.tarrada@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05