NCT06426134Completed
Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS
Pilot Study on Ketosis Impact on Signs and Symptoms of Schizophrenia and Bipolar Disorders
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 8 May 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 17 Apr 2026
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT06426134
What you commit to
- Study type: Interventional
- Participants enrolled: 28
- From 1 Dec 2024 to the primary completion date, 17 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Substance use (other than nicotine) in the week prior to study onset
Other illness
- 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
Other
- Substance use as cause of psychosis or (hypo)mania
- Intellectual disability
- Pregnancy
- Breastfeeding
Who the study is looking for
- 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:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC, dept. Psychiatry Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.