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