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NCT04395183 · ClinicalTrials.gov registry record · Phase 2
5-HTP and Creatine for Depression
A Phase 2 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT04395183: Completed Phase 2 study, sponsored by University of Utah.
NCT04395183 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04395183, a Phase 2 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study 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 + placebo, creatine + placebo, and 5-HTP + creatine, 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.
Primary Outcome
Hamilton Depression Rating Scale response rate: proportion of participants exhibiting \>=50% reduction in baseline score; maximum possible score is 52, minimum possible score is 0. Higher scores suggest more severe depression.
Interventions
- DRUG Placebo
- DRUG Creatine monohydrate
- DRUG 5-Hydroxytryptophan 100 MG
- DRUG placebo matched to 5-HTP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2024-03-01 |
| Phase | Phase 2 |
What the finished NCT04395183 record still lists
NCT04395183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04395183 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04395183 about?
NCT04395183 is a clinical study titled "5-HTP and Creatine for Depression". 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 + placebo, creatine + placebo, and 5-HTP + creatine, for 8 weeks. The ability of the interventions...
What is the current status of trial NCT04395183?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2021-03-01. Estimated completion is 2024-03-01.
What interventions are being tested in trial NCT04395183?
The interventions under investigation include: Placebo (DRUG), Creatine monohydrate (DRUG), 5-Hydroxytryptophan 100 MG (DRUG), placebo matched to 5-HTP (DRUG).
Who is sponsoring clinical trial NCT04395183?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04395183's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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