Phase 2
Completed N=43
5-HTP and Creatine for Depression
Source: ClinicalTrials.gov NCT04395183 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: 17-Item Hamilton Depression Rating Scale Responders — 0; 0; 1; 0 Participants
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 + placebo, creatine + placebo, and 5-HTP + creatine, 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 17-Item Hamilton Depression Rating Scale Responders |
0; 0; 1; 0 | — |
| SECONDARY Montgomery Asberg Depression Rating Scale Response Rate |
0; 2; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Adults age 25-40 years inclusive
- Current diagnosis of MDD identified by the SCID-5
- 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 SCID-5
- 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
- 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 or 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
Data sourced from ClinicalTrials.gov (NCT04395183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.