5-HTP and Creatine for Major Depressive Disorder

5-HTP and Creatine for Depression R33 Phase

Recruiting Phase 2 Interventional Study
Major Depressive Disorder
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
106 (estimated)
Sponsor
University of Utah · Other
Who this trial is looking for

This trial is looking for adults with major depression to study the effects of two supplements, 5-HTP and creatine. Participants will take these supplements or a placebo for 8 weeks and undergo some brain imaging and blood tests.

Are You a Good Fit for This Trial?
Must not be taking AntipsychoticsMood stabilizersNon-SSRI/SNRI antidepressants
Rules you out Renal diseasePulmonary diseaseCardiac diseaseSeizure disorderSerotonin syndrome

You may be able to join if

  • I am between 18 and 65 years old.
  • I have been diagnosed with major depressive disorder.
  • I have a current depression score of 16 or higher.
  • I have been taking an FDA-approved antidepressant for at least 8 weeks.
  • I am right-handed.
  • I have lived at a high altitude for at least 12 weeks.

You may not be able to join if

  • I have another psychiatric diagnosis besides major depression or anxiety.
  • I have a history of kidney disease.
  • I currently have colitis or diverticulitis.
  • I have a history of significant lung disease.
  • I smoke.
  • I have a history of heart disease.
  • I have a history of seizures.
  • I am currently at serious risk of suicide.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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…
Trial Locations
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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 leas…
Contacts

Brent Kious, MD

8015851418

brent.kious@hsc.utah.edu

CONTACT

Hailey Nielson, MS

801-581-3475

hailey.nielson@utah.edu

CONTACT