NCT06960811

Brief Summary

Background : Psychiatric comorbidities are common in epilepsy, affecting 50 to 70% of patients, especially when the epilepsy is focal and drug-resistant. Among these comorbidities, psychotic disorders (involving hallucinations and delusions) affect 8% of patients - that is, eight times more frequently than in the general population. Currently, the links between epilepsy and psychotic disorders are poorly understood and often overlooked by physicians, which impacts the mental health care of patients with epilepsy and leads to underdiagnosis. The aim of this research is to determine whether there are differences in epileptic symptoms between patients with a psychotic comorbidity and those without. Study design : The main objective of this research is to better understand whether certain emotional epileptic symptoms are associated with a higher risk of developing psychotic symptoms. The secondary objectives of this study are to investigate whether the level of consciousness during seizures is associated with a higher risk of developing psychotic symptoms. To meet these objectives, the study will include patients who (1) have epilepsy, (2) were hospitalized in the video-EEG unit of the Neurology Department at Central Hospital for seizure recording, and (3) underwent a psychiatric evaluation in the context of epilepsy between January 1, 2016, and April 1, 2025. The study will take place at the University Hospital Center (CHRU) of Nancy, in the Neurology Department, within the video-EEG unit led by Professor Louis Maillard. The research will involve comparing epileptic symptoms between the group of patients without psychosis and the group of patients with psychosis. Data collection will cover the five days of video-EEG hospitalization, along with information from the psychiatric evaluation, for a total duration of approximately one week per year. Information for participants: As part of the routine medical care, data is collected in medical records to ensure appropriate follow-up. For the purposes of this research, data from the medical record will be collected. No identifying information (such as name, initials, full date of birth, address, or social security number) will be collected. No additional visits or examinations will be required. Patients will not be contacted or asked to provide any new information.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

May 2, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

April 29, 2025

Last Update Submit

August 5, 2025

Conditions

Keywords

psychoses of epilepsypostictal psychosisinterictal psychosisepilepsyclinical research

Outcome Measures

Primary Outcomes (1)

  • Ictal emotions

    Clinician-assessment of ictal affective symptomatology (facial, verbal, and motor expression), based on a the visualization of an usual seizure recorded in video-EEG.

    From april 2025 to may 2025

Secondary Outcomes (3)

  • Ictal consciousness

    From april 2025 to may 2025

  • Ictal dysautonomy

    From april 2025 to may 2025

  • Type of aura

    From april 2025 to may 2025

Study Arms (2)

PEP +

Patients diagnosed with epilepsy based on video-EEG recording of seizures and with a psychotic comorbidity according to a standardized psychiatric assessment specialized in Epi-Psy

PEP -

Patients diagnosed with epilepsy based on video-EEG recording of seizures and without psychotic comorbidity according to a standardized psychiatric assessment specialized in Epi-Psy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a certain diagnosis of epilepsy, based on a video-EEG monitoring, hospitalized in tertiary center for epilepsy care, and who have a psychiatric evaluation specialized in patients with epilepsy. There are limited exclusion criteria to ensure the best representation of patients with epilepsy

You may qualify if:

  • Patients with a confirmed diagnosis of epilepsy
  • Patients hospitalized for at least 5 days for a video-EEG recording
  • Patients with a psychiatric evaluation, conducted between 01/01/2016 and 04/01/2025.
  • Adult patients able to express their opposition to the use of their data.

You may not qualify if:

  • Absence of seizure recorded during the video-EEG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center Hospital of Nancy

Nancy, Lorraine, 54000, France

Location

Related Publications (3)

  • Tarrada A, Aron O, Vignal JP, Ertan D, Maillard L, Hingray C. Anticipatory anxiety of seizures is associated with ictal emotional distress and amygdala onset seizures. Epilepsia. 2022 May;63(5):1130-1140. doi: 10.1111/epi.17215. Epub 2022 Mar 20.

    PMID: 35263805BACKGROUND
  • 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: 31654941BACKGROUND
  • Hesdorffer DC, Ishihara L, Mynepalli L, Webb DJ, Weil J, Hauser WA. Epilepsy, suicidality, and psychiatric disorders: a bidirectional association. Ann Neurol. 2012 Aug;72(2):184-91. doi: 10.1002/ana.23601. Epub 2012 Aug 7.

    PMID: 22887468BACKGROUND

MeSH Terms

Conditions

Psychotic DisordersEpilepsy, GeneralizedEpilepsy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Coraline Hingray, MD, PhD

    Psychotherapeutic Center of Nancy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 7, 2025

Study Start

May 2, 2025

Primary Completion

August 5, 2025

Study Completion

August 5, 2025

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations