Overview

5-HTP and Creatine for Depression R33 Phase

Status:
Not yet recruiting
Trial end date:
2026-07-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Utah
Treatments:
5-Hydroxytryptophan
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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