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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

110 Participants
are divided into 1 treatment group
Group A: Psychiatric prospective follow-upExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
From enrollment until 2 months after video-EEG discharge

Secondary outcomes

1

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
2

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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