CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
5-Hydroxytryptophan 100 MG +3 moredrug
Likely dose
5-Hydroxytryptophan 100 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04395183
NCT04395183Phase 2Completed

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

University of Utah·interventional·Posted May 20, 2020·Updated Jul 23, 2024

In Brief

A Phase 2 clinical trial evaluating 5-Hydroxytryptophan 100 MG, Creatine monohydrate, and 2 other interventions for Major Depressive Disorder. Completed, enrolled 43 participants across 1 site.

Detailed 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-HTP + placebo, creatine + placebo, and 5-HTP + creatine, 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 20, 2020
Enrollment StartMar 1, 2021
Primary CompletionAug 1, 2023
Study CompletionMar 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.1 years ago

Interventions

5-Hydroxytryptophan 100 MGdrug

5-HTP 100mg PO BID

Creatine monohydratedrug

Creatine monohydrate 5g PO qday

placebo matched to 5-HTPdrug

placebo matched to 5-HTP

Placebodrug

Dextrose either as loose powder (matched to creatine) or encapsulated (matched to 5-HTP)