RecruitingNot ApplicableNCT06426134

Ketosis Impact on Signs & Symptoms of Schizophrenia and Bipolar disorderS

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

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

24 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Psychosis Depressive Episode Schizophrenia and Related Disorders Bipolar and Related Disorders Manic Episode

Summary

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a ketogenic diet (a very low carbohydrate diet that causes the body to produce ketones for fuel) can improve symptoms of schizophrenia or bipolar disorder in people experiencing a first psychotic episode or a manic/depressive episode. **You may be eligible if...** - You are 18 or older - You are experiencing a first episode of psychosis (with an underlying schizophrenia-spectrum disorder) OR a manic or depressive episode (with bipolar disorder) - You are currently receiving standard psychiatric care, including medications - You are mentally able to give informed consent **You may NOT be eligible if...** - Your psychosis or mania is caused by substance use - You have used substances (other than nicotine) in the week before the study - You have an intellectual disability - You have diabetes, liver disease, kidney disease, or cardiovascular disease - You are pregnant or breastfeeding - You have a rare metabolic disorder affecting ketone processing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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