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5-HTP and Creatine for Depression

NCT04395183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-07-23

Study results available
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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.

Conditions

Interventions

DRUG

5-Hydroxytryptophan 100 MG

5-HTP 100mg PO BID

DRUG

Creatine monohydrate

Creatine monohydrate 5g PO qday

DRUG

placebo matched to 5-HTP

placebo matched to 5-HTP

DRUG

Placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-08-01
Completion
2024-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04395183 on ClinicalTrials.gov