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

Depression Clinical Trial

Official title: Exploratory Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of a Keto-Like Supplement in Depressed Patients on Functional Brain Responses to Positive and Negative Stimuli

Status Recruiting

Clinical Trial Summary

This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT06263660
• Study type: Interventional
• Source: Laureate Institute for Brain Research, Inc.
• Contact: Teresa Victor, PhD
• Phone: 918-502-5108
• Email: tvictor@laureateinstitute.org
• Status: Recruiting
• Phase: Phase 2
• Start date: January 9, 2024
• Completion date: January 2026