Investigating EEG Microstates in At-Risk Mental States
Determination of EEG Microstates Associated With Mental Disorders in At-Risk States (Détermination Des Microétats EEG associés Aux Troubles Psychiques Dans Les États à Risque - DEMETER)
This study looks at how brain activity patterns differ between people with various mental health conditions and healthy individuals to see if these patterns can help understand their diagnoses better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 15 Years to 30 Years |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06045897 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare individuals with various psychiatric disorders, including at-risk mental states, early psychosis, schizophrenia, major depressive disorder, and autism spectrum disorders, against healthy controls. Participants will undergo deep phenotyping, high-resolution EEG recordings, and voice analysis to explore the relationship between EEG microstate anomalies and psychiatric diagnoses. The study will assess differences in EEG characteristics during resting states and sleep, as well as during specific tasks. An ancillary component will examine EEG microstate properties under light hypnosis conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 15 to 30 with at-risk mental states, first-episode psychosis, major depressive disorder, autism spectrum disorder, or healthy controls.
Not a fit: Patients with severe or non-stabilized neurological disorders, suicidal risk, or a family history of psychosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new biomarkers for early diagnosis and prognosis of psychiatric disorders.
How similar studies have performed: While EEG microstates have been studied in various contexts, this specific approach focusing on at-risk mental states is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age between 15 and 30 years * subjects meeting CAARMS criteria for stage Ia or Ib mental states at risk (for stage Ia, mild or nonspecific symptoms of psychosis or severe mood disorder, and mild functional impairment; for stage Ib, moderate symptoms below intervention threshold and moderate functional impairment) * subjects meeting any DSM-5 criteria associated with a first onset of psychotic symptoms (first episode psychosis) * subjects satisfying DSM-5 criteria for depressive disorder * subjects meeting DSM-5 criteria for autism spectrum disorder * healthy control subjects recruited from the general population Exclusion Criteria: * suicidal risk * severe or non-stabilized somatic and neurological disorders * epilepsy * head trauma * IQ below 70 * for healthy control subjects, a family history of psychosis is an exclusion criterion * bipolar disorder * obsessive-compulsive disorder * substance use disorder, except for cannabis, tolerated up to 5 joints/day.
Where this trial is running
Paris
- Centre de Recherche Clinique, Hôpital Sainte-Anne, GHU Paris Psychiatrie et Neurosciences — Paris, France (Recruiting)
Study contacts
- Principal investigator: Anton Iftimovici, MD, PhD — GHU Paris Psychiatrie et Neurosciences
- Study coordinator: Anton Iftimovici, MD, PhD
- Email: anton.iftimovici@ghu-paris.fr
- Phone: 0033(0)145658179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.