Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression - Trial NCT06263660

Timeline & Enrollment

Primary Outcome

BOLD response during Monetary Incentive Delay Task

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.

ICD-10 Classifications