Status:
COMPLETED
Ketogenic Diet for Treatment-Resistant Depression: Dietary Interventions for MEntal Health Study (DIME)
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
University of Sheffield
McPin Foundation
Conditions:
Treatment Resistant Depression
Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Depression is a debilitating chronic illness affecting 1 in 6 adults in the United Kingdom (UK) at any one time. Antidepressants and psychological therapy are the main treatments, but some people do n...
Detailed Description
One in 6 people suffer from clinical depression. Antidepressants are a first-line treatment for depression, but at least 1 in 3 patients with depression do not respond to antidepressants and not every...
Eligibility Criteria
Inclusion
- Aged 18-65 years
- Have been diagnosed with depression
- Currently on an antidepressant medication for a period of 4-weeks or longer
- Have tried 2 or more antidepressant treatment trials of adequate dose and duration within the current depressive episode to which they did not fully respond. An adequate treatment trial is defined as at least 4 weeks of a medication at a minimum National Institute for Health and Care Excellence (NICE) approved dose
- With a Patient Health Questionnaire-9 (PHQ-9) total score greater than or equal to 15 at baseline
- Able to understand and be willing to adhere to the demands of the study
- Provision of written informed consent
- Have access to a tablet/computer for online assessments, follow-ups with the registered dietitian, and able to attend appointments for assessments and treatment and adhere to study procedures
- Have both a fridge and a freezer at home
- Complete all baseline assessments
Exclusion
- Currently following a low carbohydrate or ketogenic diet
- Currently following a vegan or vegetarian diet as these diets are more challenging to accommodate in a Ketogenic Diet and adding vegetables in the control group is unlikely to be seen as helpful.
- Currently receiving, or have received, in-patient psychiatric treatment or electroconvulsive therapy (electric shock to the brain under brief general anaesthetic) within the past year, or scheduled to receive such treatment during the study
- Currently using St John's wort or other remedies for depression that were bought without a doctor's prescription
- Currently have suicidal ideation with intent\* or attempted suicide within the past two months
- Ever had an eating disorder, bipolar disorder, schizophrenia, or psychosis
- Have substance use or alcohol dependence
- Have epilepsy
- Have serious food allergies (experiencing food hypersensitivity that leads to anaphylaxis or other severe symptoms, which may require hospitalisation or are life-threatening) or otherwise require a special diet that cannot be accommodated within a KD such as phenylketonuria or lactose intolerance
- Treated with insulin, sulfonylureas, Glucagon-like peptide-1 (GLP-1) agonists, or Sodium-glucose co-transporter-2 (SGLT2) inhibitors
- Women who are pregnant, planning pregnancy in the next three months, or breastfeeding
- Have a body mass index (BMI) of \<18.5 kg/m2
- Have unstable or severe medical conditions (e.g., cancer, cardiovascular, renal, lung, psychiatric, or bleeding disorders, diabetes, etc.), currently receiving cancer treatment except hormonal treatment for breast cancer or non-melanoma skin cancer treatment
- Have gallstones, renal tubular acidosis, kidney stones, small bowel malabsorption or a history of pancreatitis
- Have scheduled a major surgery in the next 3 months
- Taking part in other studies that may compromise this study or this study may compromise the other study/ies
- Have read the trial protocol or the clinical trial registration information and therefore are unblinded
- Live in the same household as another participant in the trial
- Not able to complete the online task with a tablet/computer
- Not willing to provide saliva, urine and stool samples
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06091163
Start Date
February 22 2024
End Date
September 30 2024
Last Update
February 12 2025
Active Locations (1)
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1
University of Oxford
Oxford, United Kingdom, OX2 6GG