Ketogenic Diet for Depression
(KETOMDD Trial)

Recruiting in Palo Alto (17 mi)

Overseen byElisa Brietzke, MD,PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kingston Health Sciences Centre

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?This research program will examine the feasibility as assessed through rates of adherence, tolerability, and safety of the ketogenic diet for individuals with Major Depressive Disorder (MDD) who are not achieving symptomatic remission with first line antidepressants such as the Serotonin Selective Inhibitors (SSRIs). Driven by robust data on the benefits of ketogenic diet in epilepsy and by preliminary data in animal models demonstrating its effects on depressive behaviors, there is a hypothesis that ketogenic diet could be useful to treat residual depressive symptoms. As deficits in reward and pleasure (anhedonia) are the most common residual symptoms in MDD individuals with partial response to SSRIs, the ketogenic diet could be a potential adjuvant in the treatment for depression. In addition, a preliminary assessment of neuroplasticity-related biomarkers in the plasma to determine possible biological substrates for the mechanism of action of ketogenic diet in the brain will be conducted.

Eligibility Criteria

This trial is for adults with Major Depressive Disorder (MDD) who haven't fully recovered using first-line antidepressants like SSRIs. Participants must be able to consent, meet DSM-5 criteria for MDD without psychotic features, have a moderate or severe depression score, and have been on a stable SSRI dose for at least 3 weeks.

Inclusion Criteria

Diagnostic criteria for single episode or recurrent MDD, without psychotic features, according to DSM-5, and confirmed by MINI

I have been on a stable dose of SSRIs for at least 6 weeks.

I have moderate to severe depression, with a MADRS score of 20 or more.

+2 more

Exclusion Criteria

Has evidence of alcohol or drug dependence (except for nicotine and caffeine) according to DSM-5 or within 6 months prior to enrolment

Has a current or prior diagnosis of schizophrenia spectrum disorders or bipolar disorder or related disorders, or intellectual disability, according to DSM-5

I have undergone electroconvulsive therapy in the last 6 months.

+6 more

Participant Groups

The study is testing if a ketogenic diet can help people with MDD who still have symptoms after taking SSRIs. It will look at how well participants stick to the diet and its safety. The trial also aims to understand how the diet might affect brain-related biomarkers in the blood.

1Treatment groups

Experimental Treatment

Group I: MDD patientExperimental Treatment1 Intervention

Male and female participants (N=10) with ages between 18 and 50 have a confirmed diagnosis of major depressive episode, are experiencing a current episode (following DSM-5 criteria),