Ketogenic Diet for Depression (KETOMDD Trial)

N/A

Recruiting

Led By Elisa Brietzke, MD,PhD

Research Sponsored by Queen's University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0), week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the potential of a ketogenic diet to treat residual depression symptoms not helped by SSRIs. It will also look at how the diet affects biomarkers and brain function.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the ketogenic diet may include flu-like symptoms during initial adjustment ('keto flu'), digestive changes, nutrient deficiencies if not properly managed, and possible shifts in cholesterol levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participant Adherence

Secondary study objectives

Blood glycated hemoglobin (HbA1c) in the baseline

Blood glycated hemoglobin (HbA1c) in the endpoint

Blood level of alanine aminotransferase (ALP) baseline

+40 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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),

Do I qualify?Apply below to find out