Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263660
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-05
Brief Title:
Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression
Sponsor:
Laureate Institute for Brain Research Inc
Organization:
Laureate Institute for Brain Research Inc
Study Overview
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n30 completers taken orally three times per day for 8 weeks Participants will undergo a 105-hour screeningbaseline 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 15 hours week 4 3 hours week 6 05 hours week 8 6 hours a follow-up visit at week 10 15 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 235 hours
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None