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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
Summary
This trial is testing if adding 5-HTP and creatine monohydrate to standard antidepressants can help people with depression who haven't responded to usual treatments. 5-HTP boosts serotonin, and creatine improves brain energy. The study will measure changes in brain activity and mood.
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.
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.
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 belowSelect...
I have been diagnosed with major depressive disorder.
Select...
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
17-Item Hamilton Depression Rating Scale
Secondary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression often target neurotransmitter systems and brain energy metabolism. Selective serotonin reuptake inhibitors (SSRIs) increase serotonin levels in the brain, which can improve mood and emotional stability. 5-Hydroxytryptophan (5-HTP) is a precursor to serotonin and can similarly boost serotonin levels, potentially alleviating depressive symptoms.
Creatine monohydrate influences brain energy metabolism by enhancing the availability of phosphocreatine, which supports cellular energy production and may improve brain function and mood. Understanding these mechanisms is crucial for depression patients as it helps tailor treatments to their specific neurochemical imbalances, potentially leading to more effective and personalized therapeutic strategies.
Antidepressant-like effect of creatine in mice involves dopaminergic activation.Metabolite profiling of antidepressant drug action reveals novel drug targets beyond monoamine elevation.Pretreatment metabotype as a predictor of response to sertraline or placebo in depressed outpatients: a proof of concept.
Antidepressant-like effect of creatine in mice involves dopaminergic activation.Metabolite profiling of antidepressant drug action reveals novel drug targets beyond monoamine elevation.Pretreatment metabotype as a predictor of response to sertraline or placebo in depressed outpatients: a proof of concept.
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,014 Total Patients Enrolled
22 Trials studying Depression
2,221 Patients Enrolled for Depression