← Back to Search

Other

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

KETOMDD Trial 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.Check my eligibility

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.See study design

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.

KETOMDD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participant Adherence

Secondary outcome measures

Blood glycated hemoglobin (HbA1c) in the baseline

Blood glycated hemoglobin (HbA1c) in the endpoint

Blood level of alanine aminotransferase (ALP) baseline

+40 more

KETOMDD 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

Find a Location

Who is running the clinical trial?

Queen's UniversityLead Sponsor

366 Previous Clinical Trials

121,727 Total Patients Enrolled

32 Trials studying Depression

7,143 Patients Enrolled for Depression

Elisa Brietzke, MD,PhDPrincipal InvestigatorQueen's University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this research project?

"Affirmative, the clinicaltrials.gov webpage reveals that this study is actively recruiting participants and opened on February 1st 2024 with a most recent update from November 15th 2023. Ten individuals need to be enrolled at a single location for the trial's success."

Answered by AI

Are there any openings for this research project currently?

"According to the entry on clinicaltrials.gov, this trial is actively seeking enrolment from volunteers. This research was first announced on February 1st 2024 and more recently updated November 15th 2023."

Answered by AI

Can individuals below the age of seventy partake in this medical experiment?

"This clinical trial is open to participants aged 18-55. There are 229 trials for minors and 1050 medical studies available to the elderly population."

Answered by AI

What type of individuals are deemed suitable to participate in this trial?

"This clinical trial is seeking 10 participants that suffer from depression, ranging in age between 18 and 55. To be eligible for enrolment, subjects must meet the DSM-5's criteria for single episode or recurrent Major Depressive Disorder (MDD) without psychotic features; display moderate to severe depressive syndrome as measured by a MADRS total score of 20 or higher; have taken SSRIs continually for at least 6 weeks with no changes made within the last 3 weeks; understand their consent based on medical advice given; and lack any deficiencies related to vitamins B1, B3, B6, B9 and B12 vitamin d iron zinc electroly"

Answered by AI

Recent research and studies

Neuroscience & Biobehavioral ReviewsJournal

Ketogenic Diet as a Metabolic Therapy for Mood Disorders: Evidence and Developments

Brietzke, Elisa, Rodrigo B. Mansur, Mehala Subramaniapillai, Vicent Balanzá-Martínez, Maj Vinberg, Ana González-Pinto, Joshua D. Rosenblat, Roger Ho, and Roger S. McIntyre. 2018. “Ketogenic Diet as a Metabolic Therapy for Mood Disorders: Evidence and Developments”. Neuroscience & Biobehavioral Reviews. Elsevier BV. doi:10.1016/j.neubiorev.2018.07.020.

clinicaltrials.govStudy

Ketogenic Diet Therapy Major Depressive Disorder

Dr. Elisa M Brietzke 2024. "Ketogenic Diet Therapy Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05558995.

All > Mdd