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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

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 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

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),

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Who is running the clinical trial?

Queen's UniversityLead Sponsor
371 Previous Clinical Trials
123,928 Total Patients Enrolled
32 Trials studying Depression
7,143 Patients Enrolled for Depression
Elisa Brietzke, MD,PhDPrincipal InvestigatorQueen's University
~3 spots leftby Dec 2024
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