← Back to Search

Dietary Supplement

Keto-like supplement for Depression

Phase 2

Recruiting

Led By Martin Paulus, MD

Research Sponsored by Laureate Institute for Brain Research, Inc.

Eligibility Criteria Checklist

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

Must have

Age 18-65

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 pre, week 0 post, week 8

Awards & highlights

Study Summary

This trial aims to see if a keto-like supplement can change brain function in people with moderate to severe depression. 75 participants will take either the supplement or a placebo for 8 weeks while undergoing tests

Who is the study for?

This trial is for individuals with moderate to severe depression, indicated by a score of 10 or higher on the PHQ-9 scale. Participants must be able to commit to an 8-week study with several visits and phone calls, including neuroimaging sessions and blood draws.Check my eligibility

What is being tested?

The study is testing if a keto-like supplement can affect brain responses to emotional stimuli differently than a placebo in depressed individuals. It's a double-blind trial where participants are randomly assigned either the supplement or placebo in equal numbers.See study design

What are the potential side effects?

Potential side effects are not detailed here but could include reactions similar to those experienced when starting a ketogenic diet such as fatigue, headache, dizziness, irritability, nausea, and digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 pre, week 0 post, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 pre, week 0 post, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 pre, week 0 post, week 8 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

BOLD response during Monetary Incentive Delay Task

Secondary outcome measures

BOLD response during Adjective Task

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Keto-like supplementActive Control1 Intervention

Participants will receive standardized 9.25g stick packs of the keto-like supplement. The study participants will take one of these stick packs dissolved in water three times a day (morning, noon, and evening) for 8 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive standardized 9.25g stick packs of placebo. The study participants will take one of these stick packs dissolved in water three times a day (morning, noon, and evening) for 8 weeks.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor

50 Previous Clinical Trials

5,270 Total Patients Enrolled

17 Trials studying Depression

2,582 Patients Enrolled for Depression

Martin Paulus, MDPrincipal InvestigatorLaureate Institute for Brain Research

Frequently Asked Questions

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

Is the enrollment of participants ongoing for this study?

"As per the details available on clinicaltrials.gov, this investigation is actively pursuing potential participants. The trial was initially made public on January 9th, 2024 and most recently revised on February 8th of the same year."

Answered by AI

What is the current cumulative count of individuals participating in this clinical investigation?

"Indeed, the details on clinicaltrials.gov indicate that this particular medical investigation is actively seeking eligible individuals. The trial was initially disclosed on January 9th, 2024, and last amended on February 8th of the same year. There is a need to recruit 75 participants from one designated research site."

Answered by AI

Does this research allow individuals older than 30 to participate?

"Individuals eligible for enrollment in this research study must be at least 18 years old but no older than 65."

Answered by AI

Has the Keto-like supplement received approval from the FDA?

"For this Phase 2 trial, the safety rating for the Keto-like supplement is a 2 according to our team at Power. This reflects existing data on safety but not yet efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression

2024. "Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06263660.