Status:
COMPLETED
5-HTP and Creatine for Depression
Lead Sponsor:
University of Utah
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
25-40 years
Phase:
PHASE2
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-HT...
Detailed Description
Major depressive disorder (MDD) has a lifetime prevalence of over 16%1 and is associated with reduced work productivity,2 disability,3 increased mortality,4 and increased rates of suicide attempts5 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04395183
Start Date
March 1 2021
End Date
March 1 2024
Last Update
July 23 2024
Active Locations (1)
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1
University of Utah Department of Psychiatry
Salt Lake City, Utah, United States, 84108