RECRUITINGINTERVENTIONAL

Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS

Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders

About This Trial

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: 1. 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 2. 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)

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form: Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DIETARY_SUPPLEMENT

(R)-3-hydroxybutyl (R)-3-hydroxybutyrate)

1x50g ingestion of pure dGK

OTHER

Maltodextrin, Fructose, Pectin, Sodium alginate, Sodium chloride

Isocaloric carbohydrate control (active control)

Locations (1)

Amsterdam UMC, dept. Psychiatry

Amsterdam, North Holland, Netherlands