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5-HTP and Creatine for Depression R33 Phase

RecruitingPhase 2Ages 18 Years - 65 YearsAllUniversity of Utah
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Low Dose 5-hydroxytryptophan
  • High Dose 5-hydroxytryptophan
  • Low Dose Creatine Monohydrate
  • High Dose Creatine Monohydrate
  • Placebo
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Where

1 site
University of Utah Department of Psychiatry
Salt Lake City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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