Overview
The goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (SSD), or a bipolar-spectrum disorder (BD).
The main questions it aims to answer are:
Does a ketone drink improve information processing in patients with SSD/BD?
Other questions it aims to answer are:
Does a ketone drink improve cognitive functioning in patients with SSD/BD? Does a ketone drink improve metabolism and inflammation in patients with SSD/BD? Does a ketone drink affect circadian rhythm in patients with SSD/BD?
Research will compare the effects of the ketone drink with that of an isocaloric carbohydrate drink in the same patients ('cross-over').
Participants will:
- drink a ketone drink and (after a wash-out period) an isocaloric control drink
(randomized order); after each drink:
- EEG/EMG to determine information-processing parameters (PPI and P300)
- cognitive tests
- visual analog scale of mood, energy levels, ability to focus
- indirect calorimetry to determine use of energy substrate
- blood draws
- for 5 consecutive days:
- wear a continuous glucose monitor (CGM)
- wear a non-invasive passive sweat biomarker sensor (EnLiSense device)
- register a diet and nicotine diary
- saliva sampling (max. 5x/day)
Eligibility
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