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5-HTP + Creatine for Depression

Phase 2
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults age 25-40 years inclusive
Current diagnosis of MDD identified by the SCID-5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial is testing whether 5-hydroxytryptophan and creatine monohydrate can help treat depression. Subjects will be given either 5-HTP + placebo, creatine + placebo, or 5-HTP + creatine, for 8 weeks. Brain phosophorus magnetic resonance spectroscopy, functional connectivity imaging, and plasma serotonin levels will be used to assess the ability of the interventions to affect biomarkers associated with depression.

Who is the study for?
This trial is for adults aged 25-40 with Major Depressive Disorder (MDD), a HAM-D17 score >16, and who have been on an SSRI or SNRI for at least 8 weeks. Participants must be right-handed, live above 4000 ft elevation, and not have heart disease, rheumatological conditions, pulmonary disease, seizure disorders, severe kidney issues or be current smokers.Check my eligibility
What is being tested?
The study tests if adding either 5-HTP or creatine to standard depression treatment helps improve symptoms over an 8-week period. It's a three-part test where participants are randomly given either just one of the supplements with a placebo or both together.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort from creatine and nausea from high doses of 5-HTP. There's also a risk of serotonin syndrome when combining these supplements with other antidepressants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 40 years old.
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I have been diagnosed with major depressive disorder.
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I have consistently taken an approved depression/anxiety medication for 8 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mental Depression
Secondary outcome measures
Montgomery Asberg Depression Rating Scale

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: 5-HTP + PlaceboActive Control2 Interventions
5-hydroxytryptophan 100mg PO BID plus placebo matched to creatine monohydrate
Group II: Creatine + PlaceboActive Control2 Interventions
Creatine 5g PO qday plus placebo matched to 5-HTP
Group III: Creatine + 5-HTPActive Control2 Interventions
Creatine 5g PO qday plus 5-hydroxytryptophan 100mg PO BID
Group IV: Double PlaceboPlacebo Group1 Intervention
Creatine-matched placebo and 5-HTP-matched placebo

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,088 Previous Clinical Trials
1,728,311 Total Patients Enrolled
22 Trials studying Depression
2,367 Patients Enrolled for Depression

Media Library

Creatine + 5-HTP Clinical Trial Eligibility Overview. Trial Name: NCT04395183 — Phase 2
Depression Research Study Groups: 5-HTP + Placebo, Creatine + Placebo, Creatine + 5-HTP, Double Placebo
Depression Clinical Trial 2023: Creatine + 5-HTP Highlights & Side Effects. Trial Name: NCT04395183 — Phase 2
Creatine + 5-HTP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04395183 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any particular conditions that must be met for someone to join this medical venture?

"This medical experiment is looking to enrol 172 participants aged between 25 and 40 who are suffering from melancholia. Other prerequisites include a current HAM-D17 score of > 16, right-handedness, as well as having been situated at an altitude greater than 4000 feet for at least 12 weeks."

Answered by AI

Are there any openings still available for participants of this experiment?

"Affirmative. According to the details on clinicaltrials.gov, this medical trial is currently seeking participants who meet its criteria; it was initially posted on March 1st 2021 and most recently updated April 27th 2021 with a requirement of 172 patients from one site."

Answered by AI

Are individuals aged 40 and older accepted for participation in this exploration?

"In order to meet the qualifications for this specific medical trial, applicants must be between 25 and 40 years old. Conversely, there are 192 trials tailored towards people below 18 and 969 that cater to those over 65."

Answered by AI

What potential hazards are associated with using Creatine + 5-HTP?

"The safety of Creatine + 5-HTP has been preliminarily evaluated, thus receiving a score of 2. This Phase 2 trial provides support for the compound's security but no evidence to suggest its efficacy as yet."

Answered by AI

What is the maximum capacity of participants for this research endeavor?

"Yes, the information on clinicaltrials.gov confirms that this research project is actively seeking volunteers. First posted in March 2021 and most recently updated in April of the same year, 172 participants are needed from a single location."

Answered by AI
~9 spots leftby Mar 2025