5-HTP and Creatine for Depression

NCT04395183 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB_00132830
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 17-Item Hamilton Depression Rating Scale Responders

  Hamilton Depression Rating Scale response rate: proportion of participants exhibiting \>=50% reduction in baseline score; maximum possible score is 52, minimum possible score is 0. Higher scores suggest more severe depression.

  8 weeks

Secondary Outcomes (1)

• Montgomery Asberg Depression Rating Scale Response Rate

  8 weeks

Study Arms (4)

5-HTP + Placebo

ACTIVE COMPARATOR

5-hydroxytryptophan 100mg PO BID plus placebo matched to creatine monohydrate

Drug: 5-Hydroxytryptophan 100 MG; Drug: placebo matched to 5-HTP

Creatine + Placebo

ACTIVE COMPARATOR

Creatine 5g PO qday plus placebo matched to 5-HTP

Drug: Creatine monohydrate; Drug: placebo matched to 5-HTP

Creatine + 5-HTP

ACTIVE COMPARATOR

Creatine 5g PO qday plus 5-hydroxytryptophan 100mg PO BID

Drug: 5-Hydroxytryptophan 100 MG; Drug: Creatine monohydrate

Double Placebo

PLACEBO COMPARATOR

Creatine-matched placebo and 5-HTP-matched placebo

Drug: Placebo

Interventions

5-Hydroxytryptophan 100 MG DRUG

5-HTP 100mg PO BID

Also known as: creatine monohydrate

5-HTP + Placebo; Creatine + 5-HTP

Creatine monohydrate DRUG

Creatine monohydrate 5g PO qday

Creatine + 5-HTP; Creatine + Placebo

placebo matched to 5-HTP DRUG

placebo matched to 5-HTP

5-HTP + Placebo; Creatine + Placebo

Placebo DRUG

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

Double Placebo

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults age 25-40 years inclusive
• Current diagnosis of MDD identified by the SCID-5
• Current HAM-D17 score of \> 16
• Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks
• Right-handed
• Residing at \> 4000 ft for at least 12 weeks

You may not qualify if:

• Any non-MDD and non-anxiety psychiatric diagnosis, as identified by the SCID-5
• History of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease
• Current colitis or diverticulitis
• History of or current pulmonary disease
• Current smoking
• History of cardiac disease or QTc \> 500ms
• History of fibromyalgia or any rheumatological condition
• History of or current seizure disorder
• Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
• Current treatment with an antipsychotic, mood stabilizer, or non-SSRI or SNRI antidepressant except for bupropion at FDA-approved doses or trazodone up to 200mg, or use of any supplements apart from standard multivitamins
• Positive pregnancy test, pregnancy, failure to use adequate birth control method
• Previous diagnosis of serotonin syndrome or evidence of serotonin syndrome
• Pre-existing eosinophilia (absolute eosinophil count \> 500/uL)
• Contraindications to MRI: ferromagnetic implants, implanted devices, claustrophobia

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Department of Psychiatry

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

5-Hydroxytryptophan; Creatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptophan; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Brent Kious, MD, PhD
• Organization: University of Utah

brent.kious@hsc.utah.edu

801-585-1418

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized, double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: March 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: March 1, 2024
• Last Updated: July 23, 2024
• Results First Posted: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)