NCT05895747 5-HTP and Creatine for Depression R33 Phase
| NCT ID | NCT05895747 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Utah |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2023-09-28 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 106 participants in total. It began in 2023-09-28 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05895747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05895747 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05895747 currently recruiting?
Yes, NCT05895747 is actively recruiting participants. Contact the research team at brent.kious@hsc.utah.edu for enrollment information.
Where is the NCT05895747 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT05895747 clinical trial?
NCT05895747 is sponsored by University of Utah. The trial plans to enroll 106 participants.