Using 5-HTP and creatine to treat depression

31P-MRS and Resting State Functional Connectivity Analysis of the Effects of 5-hydroxytryptophan and Creatine for Antidepressant Augmentation in Patients With SSRI/SNRI-resistant Major Depressive Disorder

This study is testing whether a combination of 5-HTP and creatine can help people with depression who live at high altitudes feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Utah (other)
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT05895747 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of 5-hydroxytryptophan (5-HTP) and creatine monohydrate as adjunct treatments for major depressive disorder (MDD). Participants will be randomly assigned to receive either low or high doses of 5-HTP combined with creatine or a placebo for 8 weeks. The study aims to assess the impact of these interventions on biomarkers related to depression through advanced imaging techniques and blood tests. The trial focuses on individuals living at high altitudes, where hypoxia may contribute to depressive symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a current diagnosis of major depressive disorder who have been living at altitudes above 4000 feet for at least 12 weeks.

Not a fit: Patients with non-MDD psychiatric disorders, significant medical conditions, or those currently at serious suicide risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients with major depressive disorder who do not respond to standard antidepressants.

How similar studies have performed: While the combination of 5-HTP and creatine for depression is relatively novel, previous studies have explored the individual effects of these agents, showing some promise in treating mood disorders.

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

Where this trial is running

Salt Lake City, Utah

• University of Utah Department of Psychiatry — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Study coordinator: Brent Kious, MD

Conditions: Major Depressive Disorder