5-HTP and Creatine for Depression R33 Phase

Description

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

Major Depressive Disorder

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Study Overview

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Study Details

Study overview

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.

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

5-HTP and Creatine for Depression R33 Phase

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Salt Lake City

University of Utah Department of Psychiatry, Salt Lake City, Utah, United States, 84108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Utah,

Study Record Dates

2026-07-31