5-HTP and Creatine for Depression R33 Phase

Launched by UNIVERSITY OF UTAH · May 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two supplements, 5-hydroxytryptophan (5-HTP) and creatine, on people with major depressive disorder (MDD). The trial will involve three groups: one will receive a lower dose of 5-HTP with creatine, another will receive a higher dose with creatine, and a third group will receive a placebo (a pill that has no active ingredients). Participants will be involved for 8 weeks, and researchers will measure how these treatments might change certain indicators related to depression in the brain.

To be eligible for the trial, participants need to be between 18 and 65 years old and have a confirmed diagnosis of major depressive disorder. They should also have been taking a specific type of depression medication (like certain antidepressants) for at least 8 weeks. This study is currently recruiting participants, and it’s important to note that individuals with certain medical conditions, like kidney disease or serious heart issues, and those who smoke or are pregnant cannot take part. If you join, you will be monitored closely, and your involvement could help researchers understand new ways to treat depression.

Gender

ALL

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 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