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5-HTP + Creatine for Depression

Phase 2

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current diagnosis of MDD identified by the MINI (Mini Neuropsychiatric Interview)

Adults age 18-65 years inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial will study if two supplements help treat depression. Subjects will take different doses of the supplements for 8 weeks and researchers will measure brain activity, connectivity, and serotonin levels.

Who is the study for?

This trial is for adults aged 18-65 with major depressive disorder (MDD), currently on an SSRI or SNRI antidepressant for at least 8 weeks, and have a moderate to severe depression score. They must be right-handed and have lived above 4000 ft elevation for the past 12 weeks.Check my eligibility

What is being tested?

The study tests two doses of 5-HTP (100mg and 200mg twice daily) combined with two doses of creatine (5g and 10g daily) against a placebo over eight weeks. It aims to see if these supplements improve depression by measuring changes in brain chemistry and connectivity.See study design

What are the potential side effects?

Potential side effects may include gastrointestinal issues like nausea or diarrhea from high-dose creatine, while high-dose 5-HTP could lead to serotonin syndrome symptoms such as confusion, agitation, or heart rate changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with major depressive disorder.

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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

17-Item Hamilton Depression Rating Scale

Secondary outcome measures

Montgomery Asberg Depression Rating Scale

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Dose 5-hydroxytryptophan and Creatine MonohydrateExperimental Treatment3 Interventions

5-HTP 100mg PO BID plus creatine 5g PO Qday

Group II: High Dose 5-hydroxytryptophan and Creatine MonohydrateExperimental Treatment2 Interventions

5-HTP 200mg PO BID plus creatine 10mg PO Qday

Group III: Double PlaceboPlacebo Group1 Intervention

Creatine-matched placebo and 5-HTP-matched placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,778,792 Total Patients Enrolled

23 Trials studying Depression

2,308 Patients Enrolled for Depression

Frequently Asked Questions

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

Is the eligibility age for this trial greater than twenty years of age?

"This clinical trial mandates that individuals aged 18 to 65 participate in the study. There are 226 studies for minors and 1025 trials available for those over retirement age."

Answered by AI

Is it possible for me to join this scientific research project?

"Eligibility for this trial mandates that potential patients suffer from depression and are between 18 to 65 years of age. Currently, 109 individuals need to be enrolled in the study."

Answered by AI

Are individuals currently being recruited for this clinical research?

"Affirmative. The information on clinicaltrials.gov demonstrates that this trial, first posted on September 1st 2023, is currently recruiting patients. With 109 participants needed from a single location, enrolment in the study is open to qualified individuals."

Answered by AI

How many participants will this clinical trial accept?

"Absolutely. Clinicaltrials.gov displays that this clinical trial, initially posted on September 1st 2023, is actively seeking participants with an updated date of November 30th 2023. Around 109 volunteers must be enrolled from a single facility."

Answered by AI

Is the concurrent administration of Low Dose 5-hydroxytryptophan and Creatine Monohydrate safe for humans?

"The safety of Low Dose 5-hydroxytryptophan and Creatine Monohydrate has been rated a 2 on the 1 to 3 scale as it is currently in Phase 2, demonstrating some evidence that suggests its safe use but not efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

5-HTP and Creatine for Depression R33 Phase

Brent Michael Kious, MD, PhD 2023. "5-HTP and Creatine for Depression R33 Phase". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05895747.