Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT05895747

5-HTP and Creatine for Depression R33 Phase

Led by University of Utah · Updated on 2025-08-08

106

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

5-HTP and Creatine for Depression R33 Phase

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults age 18-65 years inclusive
  • Current diagnosis of major depressive disorder identified by the MINI (Mini Neuropsychiatric Interview)
  • Current Hamilton Depression Rating Scale (HAM-D17) score of 16 or higher
  • Adequate adherence to any FDA approved SSRI or SNRI antidepressant for at least 8 weeks
  • Right-handed
  • Residing at altitude above 4000 feet for at least 12 weeks
Not Eligible

You will not qualify if you...

  • Any psychiatric diagnosis other than major depressive disorder or anxiety, as identified by the MINI
  • History or current diagnosis of renal disease including chronic or acute renal failure or end stage renal disease
  • Current colitis or diverticulitis
  • History or current pulmonary disease except well-controlled asthma
  • Current smoking
  • History of cardiac disease or prolonged QTc interval greater than 500 ms
  • History of fibromyalgia or any rheumatological condition
  • History or current seizure disorder
  • Current serious suicide risk as identified by the Columbia Severity Suicide Rating Scale
  • Current treatment with antipsychotics, mood stabilizers, or non-SSRI/SNRI antidepressants except bupropion at FDA-approved doses or trazodone up to 200 mg
  • Use of supplements other than standard multivitamins
  • Positive pregnancy test, pregnancy, or failure to use adequate birth control
  • Previous diagnosis or evidence of serotonin syndrome
  • Pre-existing eosinophilia with absolute eosinophil count over 500/uL
  • Contraindications to MRI including ferromagnetic implants, implanted devices, or claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Utah Department of Psychiatry

Salt Lake City, Utah, United States, 84108

Actively Recruiting

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Research Team

B

Brent Kious, MD

CONTACT

H

Hailey Nielson, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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