What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for depression, such as SSRIs, can have side effects including nausea, headache, dizziness, dry mouth, insomnia, and sexual dysfunction. 5-HTP, which increases serotonin levels, may cause gastrointestinal issues, heartburn, and drowsiness. Creatine monohydrate, which influences brain energy metabolism, is generally well-tolerated but can cause weight gain, gastrointestinal discomfort, and muscle cramping. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for depression that focus on increasing serotonin levels, similar to 5-HTP. These include SSRIs like fluoxetine, sertraline, and escitalopram, which are first-line treatments for depression. SNRIs such as venlafaxine and duloxetine also target serotonin and norepinephrine to treat depression. While creatine monohydrate, which influences brain energy metabolism, is not specifically approved for depression, its potential benefits are being explored in clinical trials.

What other types of research exist?

Promising novel alternatives for depression treatment in 2024 could include: 1) Ketamine and its derivatives, which have shown rapid antidepressant effects by modulating glutamate neurotransmission. 2) Psilocybin, a psychedelic compound that has demonstrated potential in clinical trials for treatment-resistant depression. 3) N-acetylcysteine (NAC), which influences glutathione levels and has shown promise in improving mood disorders. 4) Omega-3 fatty acids, which have anti-inflammatory properties and can influence brain function. 5) Transcranial magnetic stimulation (TMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

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

0 / 2Eligibility criteria met

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.