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5-HTP and Creatine for Depression R33 Phase

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 30, 2026 → Jul 1, 2027
See other at-risk trials from University of Utah

Record History

  1. Primary completion pushed from Jun 30, 2026 to Jul 1, 2027 Completion pushed from Jul 31, 2026 to Sep 30, 2027v8 Show 1 more changeShow less
    • Completion pushed from Jul 31, 2026 to Sep 30, 2027
  2. Site contact updatedv7
  3. Enrollment target: 109 to 106v6
  4. Start date: Sep 1, 2023 to Sep 28, 2023v5
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v4 Show 1 more changeShow less
    • Study sites: 0 to 1
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jul 3, 2023 to Sep 1, 2023v3
  2. Study description revisedv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Utah
302 trials monitored
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Depression
2,998 trials monitored
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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.
Trial Details
NCT Number NCT05895747
Lead Sponsor University of Utah
Conditions Major Depressive Disorder
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov