Clinical Trial

5-HTP and Creatine for Depression R33 Phase

Recruiting Phase 2
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Record status
This record was last updated August 8, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a three-armed clinical trial examining the effect of 5-hydroxytryptophan and creatine monohydrate as augmenting agents for the treatment of depression. Subjects will be randomized between 5-HTP 100mg BID + creatine 5g daily, 5-HTP 200mg BID + creatine 10g daily, vs double placebo, for 8 weeks. The ability of the interventions to affect biomarkers associated with depression will be assessed using brain phosphorus magnetic resonance spectroscopy, functional connectivity imaging, and plasma serotonin levels.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-05-25; most recent amendment 2025-08-04.
Status change: Not Yet Recruiting → Recruiting 2023-11-30
Trial Details
NCT Number NCT05895747
Lead Sponsor University of Utah
Conditions Major Depressive Disorder
Enrollment 106 participants
Start Date 2023-09-28
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-08