Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05895747
PHASE2

5-HTP and Creatine for Depression R33 Phase

Sponsor: University of Utah

View on ClinicalTrials.gov

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 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2023-09-28

Completion Date

2026-07-31

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DRUG

Low Dose 5-hydroxytryptophan

5-hydroxytryptophan 100mg PO BID

DRUG

High Dose 5-hydroxytryptophan

5-hydroxytryptophan 200mg PO BID

DRUG

Low Dose Creatine Monohydrate

Creatine monohydrate 5g PO qday

DRUG

High Dose Creatine Monohydrate

Creatine monohydrate 10g PO qday

DRUG

Placebo

Creatine-matched placebo and 5-HTP-matched placebo; Placebo will be dextrose either encapsulated (5-HTP matched) or as loose powder (creatine matched)

Locations (1)

University of Utah Department of Psychiatry

Salt Lake City, Utah, United States