Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
106 (estimated)
Sponsor
University of Utah · Other
Who this trial is looking for
This trial is looking for adults with major depression to study the effects of two supplements, 5-HTP and creatine. Participants will take these supplements or a placebo for 8 weeks and undergo some brain imaging and blood tests.
Are You a Good Fit for This Trial?
Must not be takingAntipsychoticsMood stabilizersNon-SSRI/SNRI antidepressants
Rules you outRenal diseasePulmonary diseaseCardiac diseaseSeizure disorderSerotonin syndrome
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with major depressive disorder.
I have a current depression score of 16 or higher.
I have been taking an FDA-approved antidepressant for at least 8 weeks.
I am right-handed.
I have lived at a high altitude for at least 12 weeks.
You may not be able to join if
I have another psychiatric diagnosis besides major depression or anxiety.
I have a history of kidney disease.
I currently have colitis or diverticulitis.
I have a history of significant lung disease.
I smoke.
I have a history of heart disease.
I have a history of seizures.
I am currently at serious risk of suicide.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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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 leas…
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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