Status:

RECRUITING

5-HTP and Creatine for Depression R33 Phase

Lead Sponsor:

University of Utah

Conditions:

Major Depressive Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

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-HT...

Detailed Description

Major depressive disorder (MDD) has a lifetime prevalence of over 16% and is associated with reduced work productivity, disability, increased mortality, and increased rates of suicide attempts and com...

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

Key Trial Info

Start Date :

September 28 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2026

Estimated Enrollment :

106 Patients enrolled

Trial Details

Trial ID

NCT05895747

Start Date

September 28 2023

End Date

July 31 2026

Last Update

August 8 2025

Active Locations (1)

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1

University of Utah Department of Psychiatry

Salt Lake City, Utah, United States, 84108