💬In plain words
What the trial is, and whether it could suit you
Objective The objective is to recruit antipsychotic-naïve patients at the first diagnosis with a first-episode schizophrenia disorder (FES) to study ketone metabolism of the brain via PET neuroimaging. Participants will undergo PET neuroimaging at baseline before start of antipsychotic treatment and after 4-8 weeks of antipsychotic treatment including an additional clinical follow-up visit after 6 months. In addition, a healthy control group with one baseline visit will be recruited.
Study design Non-interventional neuroimaging study with pre-defined follow-up visits.
Patients Patients with a FES (ICD-10: F20) aged 18-35 years who are antipsychotic-naïve including age- and sex-matched healthy controls.
Sample size This is an observational pilot project. Currently, no studies have measured brain ketone metabolism before and after AP intake. Assuming a 50% dropout rate at follow-up, the
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
Inclusion criteria for patients with FES
1. Age 18-35 years
2. Diagnosed with FES (ICD-10: F20)
3. Able to give informed oral and written consent.
Inclusion criteria for healthy controls
1. Age 18-35 years
2. No mental disorder (ICD-10: F00-99)
3. Able to give informed oral and written consent.
Exclusion Criteria:
Exclusion criteria for patients with FES
1. Any coercive measure including patients in forensic psychiatry
2. In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study.
3. Previous use of AP at an antipsychotic dose (except for Risperidone ≤0.5 mg, Abilify ≤2.5 mg, Seroquel ≤50 mg or Zyprexa ≤2.5 mg) for more than 2 continuous weeks in the past year and/or 6 weeks over a lifetime
4. Use of an antipsychotic in the last 3 months before inclusion at a dose greater than:
4.1 Seroquel/Quetiapine 50 mg 4.2 Risperdal/Risperidone 0.5 mg
5. Comorbidity: Borderline intelligence or intellectual disability, autism spectrum disorder, decompensated substance use disorder, psychosis induced by a medical condition or psychosis induced by medication or drug use.
6. Pregnancy, childbirth within the past 6 months, or breastfeeding. Female participants should use an effective contraception.
7. Contraindications to MRI (metal, severe claustrophobia).
8. Acute suicidal thoughts (e.g., resulting in hospitalization)
9. Diabetes mellitus type 1. History of severe head trauma, stroke, chemotherapy or brain surgery. Hypo- or hyperthyroidism. Epilepsy. Systemic glucocorticoid hormone treatment.
10. Other conditions interfering with participation according to the qualified physician's judgment.
Exclusion criteria for healthy controls
1. Previous use of an antipsychotic dose (except for Risperidone ≤0.5 mg, Abilify ≤2.5 mg, Seroquel ≤50 mg or Zyprexa ≤2.5 mg) for more than 2 continuous weeks in the past year and/or 6 weeks over a lifetime
2. Use of AP in the last 3 months before inclusion at a dose greater than:
1. Seroquel/Quetiapine 50 mg
2. Risperdal/Risperidone 0.5 mg
3. Pregnancy, childbirth within the past 6 months, or breastfeeding. Female participants should use an effective contraception.
4. Contraindications to MRI (metal, severe claustrophobia).
5. Diabetes mellitus type 1. History of severe head trauma, stroke, chemotherapy or brain surgery. Hypo- or hyperthyroidism. Epilepsy. Systemic glucocorticoid hormone treatment.
6. Other conditions interfering with participation according to the qualified physician's judgment.
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