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

• Conditions: bipolaire stoornissen; schizophrenia psychotic disorder / bipolar disorder; 10039628

• Registration Number: NL-OMON56800
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Patients diagnosed with schizophrenia or bipolar disorder who are in at least
partial remission receiving standard care
able to give informed consent
age 18 - 65 years old

Exclusion Criteria

Acute/florid psychosis, acute mania (unremitted)
inability to give (informed) consent
age < 18 or > 65 years old.
liver function disorder
kidney function disorder
cardiovascular disease
ketone body metabolism disorder
diabetes
pregnancy or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is percent change between intervention (dGK<br /><br>ingestion) vs control (isocaloric gold standard drink) in PPI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures include percent change between intervention and<br /><br>control drink: in basal EEG7, P300 ERP, cognitive test scores;<br /><br>patient-experienced improvement in energy level, mood, ability to focus (visual<br /><br>analogue scale); metabolic and immune parameters (blood, sweat and saliva<br /><br>biomarkers; indirect calorimetry). </p><br>