5-HTP and Creatine for Depression R33 Phase
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT05895747
- Run by
- University of Utah
- People needed
- 106
- Starts
- 2023-09-28
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2025-08-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults age 18-65 years inclusive
- Current diagnosis of MDD identified by the MINI (Mini Neuropsychiatric Interview)
- Current HAM-D17 score of >= 16
- Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks
- Right-handed
- Residing at > 4000 ft for at least 12 weeks
You may not qualify if…
- Any non-MDD and non-anxiety psychiatric diagnosis, as identified by the MINI
- History of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease
- Current colitis or diverticulitis
- History of or current pulmonary disease (except well controlled asthma)
- Current smoking
- History of cardiac disease or QTc > 500ms
- History of fibromyalgia or any rheumatological condition
- History of or current seizure disorder
- Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
- Current treatment with an antipsychotic, mood stabilizer, or non-SSRI/SNRI antidepressant except for bupropion at FDA-approved doses or trazodone up to 200mg, or use of any supplements apart from standard multivitamins
- Positive pregnancy test, pregnancy, failure to use adequate birth control method
- Previous diagnosis of serotonin syndrome or evidence of serotonin syndrome
- Pre-existing eosinophilia (absolute eosinophil count > 500/uL)
- Contraindications to MRI: ferromagnetic implants, implanted devices, claustrophobia
Where it is running
- University of Utah Department of Psychiatry — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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