Tests 5-HTP and creatine added to antidepressants for depression not helped by standard treatment
Tests 5-HTP and creatine, added to antidepressant treatment, in adults with major depressive disorder.
Plain-language title generated from the registry record
Registry title: 5-HTP and Creatine for Depression R33 Phase
Key facts
- Where
- Salt Lake City, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05895747, who can take part
Where in United States
- University of Utah Department of PsychiatrySalt Lake City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Utah
- Trial code
- NCT05895747
- Record updated
- 27 August 2026
- Original description
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.Read full original descriptionShow less
31P-MRS and Resting State Functional Connectivity Analysis of the Effects of 5-hydroxytryptophan and Creatine for Antidepressant Augmentation in Patients With SSRI/SNRI-resistant Major Depressive Disorder
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.
Inclusion: 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: 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; Previous diagnosis of serotonin syndrome or evidence of serotonin syndrome; Contraindications to MRI: ferromagnetic implants, implanted devices, claustrophobia; 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; History of or current pulmonary disease (except well controlled asthma); History of fibromyalgia or any rheumatological condition; History of or current seizure disorder; Positive pregnancy test, pregnancy, failure to use adequate birth control method; History of cardiac disease or QTc > 500ms; Pre-existing eosinophilia (absolute eosinophil count > 500/uL); Current colitis or diverticulitis; Current smoking; Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale.