5-HTP and Creatine for Depression R33 Phase

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05895747
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Low Dose 5-hydroxytryptophan — DRUG
    5-hydroxytryptophan 100mg PO BID
  • High Dose 5-hydroxytryptophan — DRUG
    5-hydroxytryptophan 200mg PO BID
  • Low Dose Creatine Monohydrate — DRUG
    Creatine monohydrate 5g PO qday
  • High Dose Creatine Monohydrate — DRUG
    Creatine monohydrate 10g PO qday
  • Placebo — DRUG
    Creatine-matched placebo and 5-HTP-matched placebo; Placebo will be dextrose either encapsulated (5-HTP matched) or as loose powder (creatine matched)

Study Details

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.

Key Dates

Start date
Sep 28, 2023
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
106 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Dose 5-hydroxytryptophan and Creatine Monohydrate
    5-HTP 100mg PO BID plus creatine 5g PO Qday
  • Experimental: High Dose 5-hydroxytryptophan and Creatine Monohydrate
    5-HTP 200mg PO BID plus creatine 10mg PO Qday
  • Placebo Comparator: Double Placebo
    Creatine-matched placebo and 5-HTP-matched placebo

Primary Outcome Measure

17-Item Hamilton Depression Rating Scale [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Utah Department of PsychiatrySalt Lake CityUtah84108
Brent Kious
[email protected]
8015851418

Find similar trials in Salt Lake City, UT

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Utah Department of Psychiatry· Salt Lake City, UT

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