Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression
Recruiting
Phase 2
Interventional Study
Depression
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 75 (estimated)
- Sponsor
- Laureate Institute for Brain Research, Inc. · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
* Bod…
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