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NCT06263660 · ClinicalTrials.gov registry record · Phase 2
Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression
A Phase 2 study of Depression, sponsored by Laureate Institute for Brain Research.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT06263660 is a Phase 2 study of Depression that is actively recruiting participants, run by Laureate Institute for Brain Research. The registered enrollment target is 75 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06263660, a Phase 2 study of Depression, is actively recruiting participants, sponsored by Laureate Institute for Brain Research.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Keto-like supplement
Study Locations (1)
Oklahoma
- Laureate Institute for Brain Research - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-01-09 |
| Est. Completion | 2026-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06263660
The ClinicalTrials.gov registry entry for NCT06263660 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (90% lower). The listed sponsor is Laureate Institute for Brain Research, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06263660 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.
Frequently Asked Questions
What is clinical trial NCT06263660 about?
NCT06263660 is a clinical study titled "Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression". 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 w...
What is the current status of trial NCT06263660?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2024-01-09. Estimated completion is 2026-01.
What conditions does trial NCT06263660 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT06263660?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Keto-like supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06263660?
This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06263660 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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