Ketogenic Diet for Depression

ConditionsDepressive Disorder Major Depressive Disorder Depression, Bipolar

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorUniversity Psychiatric Clinics Basel

About this trial

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 increasing interest in a promising intervention: the ketogenic diet. This diet restricts carbohydrate intake, promoting the breakdown of fats into circulating ketone bodies, which can act as an additional energy source for the brain, potentially reducing its reliance on glucose. While various sources of evidence suggest the potential benefits of the ketogenic diet for individuals with depression, robust clinical studies on its efficacy in depressed patients are lacking. Our goal is to conduct an eight-week, assessor-blinded, randomized controlled trial to investigate the therapeutic effects of a very low-carbohydrate, high-fat ketogenic diet compared to an active comparator diet in individuals with depression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Ketogenic Diet
Other intervention
The ketogenic diet intervention, administered as a Modified Atkins Diet, involves a significantly reduced daily carbohydrate intake, typically less than 20 grams of net carbs. This approach primarily relies on higher fat consumption to induce ketosis, a metabolic state characterized by elevated ketone body production, serving as an alternative brain fuel source.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Ketogenic Diet ArmExperimental treatment 1 intervention

Group B: Conventional Healthy Mixed Diet ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

Depressive Symptoms Severity

* Assessment Tool: Hamilton Depression Rating Scale (HAM-D17) * Scale Range: 0 to 54 (higher scores indicate more severe depressive symptoms)

Time frame