University of Utah
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.
Major depressive disorder (MDD) has a lifetime prevalence of over 16% and is associated with reduced work productivity, disability, increased mortality, and increased rates of suicide attempts and completed suicides. Unfortunately, \~34% fail to respond to standard ADs (ADs). Environmental and patient-level factors that increase the risk of MDD could pinpoint novel mechanisms underlying the disorder. One such factor may be relative hypoxia. Persons with hypoxic medical conditions, such as asthma and chronic obstructive pulmonary disease, are at higher risk of depression and suicide compared to…
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 curren…
5-hydroxytryptophan 100mg PO BID
5-hydroxytryptophan 200mg PO BID
Creatine monohydrate 5g PO qday
Creatine monohydrate 10g PO qday
Creatine-matched placebo and 5-HTP-matched placebo; Placebo will be dextrose either encapsulated (5-HTP matched) or as loose powder (creatine matched)
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