BridgeMD
New treatment option for Major Depressive Disorder
Official title 5-HTP and Creatine for Depression R33 Phase
ClinicalTrials.gov ID: NCT05895747
What this study is testing
What is Low Dose 5-hydroxytryptophan?
Low Dose 5-hydroxytryptophan is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for major depressive disorder.
Also referred to as 5-HTP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.