Status:
NOT_YET_RECRUITING
Ketogenic Diet for Depression
Lead Sponsor:
University Psychiatric Clinics Basel
Conditions:
Depressive Disorder
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Globally, it's estimated that around 300 million people are affected by depressive illness, and even with access to modern mental health care, long-term recovery is uncommon. Recently, there has been ...
Detailed Description
Major depressive disorder (MDD) is the second leading contributor to the global burden of chronic diseases, as measured by years lived with disability. Additionally, MDD is associated with an increase...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Unequivocal diagnosis of major depressive disorder or bipolar depression according to ICD-10 and ICD-11 (as soon as approved in Switzerland) criteria
- Age ≥18 years
- The patient can give informed consent as documented by signature
- Interest in trying a dietary intervention
- Participants must refrain from using any non-prescribed psychotropic agents during the study period including alcohol and illicit drugs such as cannabis; long term pain medication, caffeine and nicotine are excluded from that rule
- Exclusion criteria:
- Inability to follow the study procedures, e.g., because of a language barrier, neurological and interfering mental disorders, dementia
- Anorexia nervosa
- BMI \<18.5 kg/m2
- Pregnancy or breast feeding
- Current electroconvulsive therapy (ECT)
- Concurrent ketamine therapy
- Inability to follow the procedures of the study, e.g. due to language barrier, neurological and interfering mental disorders, high-grade dementia, etc.
- Porphyria
- Type 1 diabetes
- Insulin-dependent type 2 diabetes
- Contraindicated medical conditions; besides rare hereditary metabolic disorders (typically diagnosed in childhood), contraindications comprise acute pancreatitis, nephrolithiasis, advanced renal failure, advanced liver failure, advanced congestive heart failure, advanced pulmonary disease with respiratory failure, and concurrent use of SGLT2 inhibitors
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06105762
Start Date
January 1 2024
End Date
July 1 2027
Last Update
October 30 2023
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