Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Laureate Institute for Brain Research, Inc.
You may qualify if…
- ✓ Meets the Diagnostic and statistical manual - 5 (DSM-5) diagnostic criteria for MDD without psychotic features (past or present), as confirmed by the M.I.N.I v7.0
- ✓ PHQ-9 score of ≥10
- ✓ C-Reactive Protein (CRP) value \> 1
- ✓ Age 18-65
- ✓ Consent ability and written consent
- ✓ Body Mass Index (BMI) between 19 and 38 kg/m2
- ✓ Medically stable based on clinical laboratory tests, medical history and vital signs
- ✓ No intention to become pregnant during the study
You may not qualify if…
- ✕ Has a current or recent history of clinically significant suicidality
- ✕ Has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 12 months before screening
- ✕ Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, cannabinoids, amphetamine/methamphetamine and ecstasy)
- ✕ Has a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia, bulimia), or learning disability or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g. narcissistic personality, borderline personality disorder)
- ✕ Change in medication dose and/or frequency within the last 6 weeks. Participants must be on stable medications for 6 weeks prior to enrollment.
- ✕ Plans to change medication dose/frequency during the course of the study. Must plan to remain on stable dose for the duration of the study, unless otherwise indicated by their provider during the course of the study.
- ✕ Plans to take vitamins and/or mineral supplements during the study. Must refrain for the duration of the study
- ✕ Unable to complete MRI scans
Where it's recruiting
Tulsa
Source: ClinicalTrials.gov · NCT06263660 · last updated 2026-04-20