drugset / Trial / NCT05895747
5-HTP and Creatine for Depression R33 Phase
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2023-09-28
- Primary completion
- 2026-06-30
- Completion
- 2026-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 5-Hydroxytryptophan | Other / unclassified | 100 mg | Oral |
| Subject | 5-Hydroxytryptophan | Other / unclassified | 200 mg | Oral |
| Subject | Creatine | Other / unclassified | 5 g | Oral |
| Subject | Creatine | Other / unclassified | 10 g | Oral |