NCT06045897 EEG Microstates Across At-Risk Mental States
| NCT ID | NCT06045897 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier St Anne |
| Condition | Psychotic Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2023-05-30 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2023-05-30 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to compare subjects with at-risk-mental-state, early psychosis, schizophrenia, depression, and autism spectrum disorders, with healthy controls (N = 21 x 6). The main questions it aims to answer are: * are EEG microstate anomalies associated with diagnosis, clinical and functional prognosis, both in resting conditions and during sleep ? * are EEG microstates anomalies associated with differences in sensorimotor integration, prosodic and conversational, interoceptive, and narrative self ? * an ancillary study will be to see whether in healthy controls EEG microstate properties vary under light hypnosis conditions. Participants will: * undergo deep phenotyping based on psychopathology and neuropsychological assessments * undergo a high-resolution EEG (64 electrodes) with a resting period and a sensorimotor task; and healthy controls will have a light hypnosis period. * undergo a recording of the characteristics of their voice (tone, prosody) * undergo a one-night polysomnography * undergo MRI and biological sampling for multi-omic analyses * undergo a virtual reality experience
Eligibility 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.
Contact & Investigator
Anton Iftimovici, MD, PhD
PRINCIPAL INVESTIGATOR
GHU Paris Psychiatrie et Neurosciences
Frequently Asked Questions
Who can join the NCT06045897 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 30 Years, studying Psychotic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06045897 currently recruiting?
Yes, NCT06045897 is actively recruiting participants. Contact the research team at anton.iftimovici@ghu-paris.fr for enrollment information.
Where is the NCT06045897 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06045897 clinical trial?
NCT06045897 is sponsored by Centre Hospitalier St Anne. The principal investigator is Anton Iftimovici, MD, PhD at GHU Paris Psychiatrie et Neurosciences. The trial plans to enroll 126 participants.