Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT06426134
Eligibility Criteria:
Inclusion Criteria:
* Patients with a first-episode psychosis (underlying schizophrenia-spectrum disorder), or patients with a (hypo)manic or depressive episode (underlying bipolar disorder)
* Age \>= 18 years old
* Receiving standard care (including antipsychotic and mood stabilizing medication)
* Mentally competent to give informed consent:
Exclusion Criteria:
* Substance use as cause of psychosis or (hypo)mania
* Substance use (other than nicotine) in the week prior to study onset
* Intellectual disability
* Diabetes mellitus (type 1 or type 2)
* Metabolic disease impacting ketone metabolism (NB: these are rare disorders diagnosed during childhood)
* Liver disease
* Kidney disease
* Cardiovascular disease
* Pregnancy
* Breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06426134
Study Brief:
Protocol Section:
NCT06426134