The Effects of a Medically Supervised Ketogenic Diet on Major Depressive Disorder: A Pilot Study

Abstract

Major depressive disorder is a potentially severe mental illness characterized by two core symptoms, the presence of a despondent mood and anhedonia. The first mainline treatment option, selective serotonin reuptake inhibitors, is ineffective in relieving the core symptoms of depression in 33% of participants, with residual symptoms also persisting in approximately a third of all patients post-therapy. Studies conducted on humans and animals have identified the role of the ketogenic diet in eliciting potent neuromodulatory effects throughout the brain. However, this intervention has not been systematically investigated in individuals with major depressive disorder. Participants will be recruited to participate in a 12-week open-label study assessing the feasibility of implementing a medically supervised ketogenic diet as an adjunctive therapy to treat individuals with major depressive disorder. Feasibility assessment included analysis of participant adherence and tolerability to the ketogenic diet. This study will consist of a 2-week induction phase, whereby participants are safely introduced to the ketogenic diet, followed by a subsequent 10-week maintenance phase. Feasibility and clinical data will be collected on a weekly basis from start to study endpoint. A total of thirty-one participants approached to participate in the study, though only seven met the appropriate criteria for inclusion. Four have successfully enrolled in the study and are currently consuming the medically supervised ketogenic diet. Twenty-nine of the thirty-one (93.5%) participants to approach the study were female, with zero males successfully enrolling in the study. Analysis of participant recruitment strategies revealed that self-referrals via social media were most effective. Additionally, physician referrals were unsuccessful, as only a single participant was directed to the study via a physician despite direct contact with thirty doctors. The feasibility data collection is still ongoing and was significantly delayed due to COVID-19. Four participants are currently enrolled in the study and consuming the medically supervised ketogenic diet. Data will be analyzed and disseminated at the study endpoint.