5-HTP + Creatine for Depression
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Utah
Must be taking: SSRI, SNRI
Must not be taking: Antipsychotics, Mood stabilizers
Disqualifiers: Renal disease, Pulmonary disease, Cardiac disease, Seizure disorder, others
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you stay on an existing SSRI or SNRI medication for at least 8 weeks before joining. You cannot be on antipsychotics, mood stabilizers, or non-SSRI/SNRI antidepressants, except for bupropion or trazodone at specified doses.
What evidence supports the effectiveness of the drug 5-HTP and Creatine for treating depression?
Research suggests that combining 5-HTP and creatine with standard antidepressants may help women with depression who haven't responded to other treatments, as it could improve serotonin levels and brain energy. Additionally, studies show that 5-HTP alone has some effectiveness in reducing depressive symptoms, similar to other antidepressants.
12345Is the combination of 5-HTP and Creatine safe for humans?
5-HTP has been studied for depression and is generally considered safe, but it can have side effects like serotonin syndrome (a potentially dangerous condition caused by too much serotonin) and eosinophilia myalgia syndrome (a rare condition causing muscle pain and high white blood cell counts). Creatine is commonly used as a supplement and is generally safe, but combining it with 5-HTP for depression is still being studied, so it's important to consult with a healthcare provider.
12346How does the treatment of 5-HTP and creatine for depression differ from other treatments?
This treatment is unique because it combines 5-HTP, a serotonin precursor, with creatine, which may enhance brain energy, to potentially improve depression symptoms in women who do not respond to standard antidepressants. This combination aims to address both serotonin production and brain bioenergetics, offering a novel approach compared to traditional antidepressants.
12357Eligibility Criteria
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.Inclusion Criteria
You are right-handed.
I have consistently taken an approved depression/anxiety medication for at least 8 weeks.
I have been diagnosed with major depressive disorder.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to receive either low dose 5-HTP and creatine, high dose 5-HTP and creatine, or double placebo for 8 weeks
8 weeks
Regular visits for monitoring and assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Utah Department of PsychiatrySalt Lake City, UT
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Who Is Running the Clinical Trial?
University of UtahLead Sponsor
References
An Open-Label Pilot Study of Combined Augmentation With Creatine Monohydrate and 5-Hydroxytryptophan for Selective Serotonin Reuptake Inhibitor- or Serotonin-Norepinephrine Reuptake Inhibitor-Resistant Depression in Adult Women. [2018]Many women with major depressive disorder (MDD) respond inadequately to standard treatments. Augmentation of conventional antidepressants with creatine monohydrate and 5-hydroxytryptophan (5-HTP) could correct deficits in serotonin production and brain bioenergetics associated with depression in women, yielding synergistic benefit. We describe an open-label study of 5-HTP and creatine augmentation in women with MDD who had failed selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) monotherapy.
Serotonin a la carte: supplementation with the serotonin precursor 5-hydroxytryptophan. [2022]This paper reviews the preclinical and clinical evidence regarding the use of the dietary supplement 5-hydroxytryptophan (5-HTP) for the treatment of depression. In the absence of supplementation with exogenous 5-HTP, the amount of endogenous 5-HTP available for serotonin synthesis depends on the availability of tryptophan and on the activity of various enzymes, especially tryptophan hydroxylase, indoleamine 2,3-dioxygenase, and tryptophan 2,3-dioxygenase (TDO). Factors affecting each of these are reviewed. The amount of 5-HTP reaching the central nervous system (CNS) is affected by the extent to which 5-HTP is converted to serotonin in the periphery. This conversion is controlled by the enzyme amino acid decarboxylase, which, in the periphery, can be blocked by peripheral decarboxylase inhibitors (PDIs) such as carbidopa. Preclinical and clinical evidence for the efficacy of 5-HTP for depression is reviewed, with emphasis on double-blind, placebo-controlled (DB-PC) trials. Safety issues with 5-HTP are also reviewed, with emphasis on eosinophilia myalgia syndrome (EMS) and serotonin syndrome.
Measurement of 5-hydroxyindole compounds during L-5-HTP treatment in depressed patients. [2013]L-5-hydroxytryptophan (L-5-HTP), an immediate serotonin precursor, was given to the hospitalized depressed patients in an open clinical trial of the Phase 2 study for antidepressive effects of the agent. A relatively small dose, 150mg orally for seven days, was employed, and seven of 14 patients responded to the treatment with mild or moderate emelioration of their depressive symptoms. Urinary excretion levels and plasma concentrations of three 5-hydroxyindole compounds, 5-HTP, 5-HT and 5-HIAA, were measured during the drug treatment. Approximately 70% of the orally administered dose of L-5-HTP was recovered from the urine of depressed patients. Major part of urinary indoleamine metabolites was free and conjugate 5-HIAA. Excretion levels of these compounds in urine were not consistenly altered in the depressed patients as compared to those in normal subjects. Clinical response to L-5-HTP treatment appeared to have some correlation with the biochemical measures in the depressed patients, that is, non-responders exhibited significantly lower excretion levels of 5-HT and 5-HIAA in urine, and lower plasma levels of 5-HT than responders. Administered L-5-HTP may not be fully utilized in the depressed patients who did not react to the agent.
Measurement of 5-hydroxyindole compounds during L-5-HTP treatment in depressed patients. [2019]L-5-hydroxytryptophan (L-5-HTP), and immediate serotonin precursor, was given to the hospitalized depressed patients in an open clinical trial of the Phase 2 study for antidepressive effects of the agent. A relatively small dose, 150 mg orally for seven days, was employed, and seven of 14 patients responded to the treatment with mild or moderate amelioration of their depressive symptoms. Urinary excretion levels and plasma concentrations of three 5-hydroxyindole compounds, 5-HTP, 5-HT and 5-HIAA, were measured during the drug treatment. Approximately 70% of the orally administered dose of L-5-HTP was recovered from the urine of depressed patients. Major part of urinary indoleamine metabolites was free and conjugate 5-HIAA. Excretion levels of these compounds in urine were not consistently altered in the depressed patients as compared to those in normal subjects. Clinical response to L-5-HTP treatment appeared to have some correlation with the biochemical measures in the depressed patients, that is, non-responders exhibited significantly lower excretion levels of 5-HT and 5-HIAA in urine, and lower plasma levels of 5-HT than responders. Administered L-5-HTP may not be fully utilized in the depressed patients who did not react to the agent.
Comparative study of efficacy of l-5-hydroxytryptophan and fluoxetine in patients presenting with first depressive episode. [2016]Role of l-5-hydroxytryptophan (l-5-HTP) in depression is relatively less studied but the literature has shown its robust role in depression. The present randomized double blind study was undertaken to assess the role of l-5-HTP as an antidepressant and to compare its antidepressant efficacy with fluoxetine in first depressive episode patients of Indian population.
5-Hydroxytryptophan: a review of its antidepressant efficacy and adverse effects. [2013]Alterations in serotonin metabolism may be an important factor in the etiology and treatment of depression. In this regard, 5-hydroxytryptophan (5-HTP), a serotonin precursor, has been given to patients with depression. Although a review of these studies suggests that 5-HTP possesses antidepressant properties, additional trials are clearly indicated. Following a discussion of the pharmacology of 5-HTP, the authors highlight adverse effects associated with its administration to depressed patients, neurologic subjects, and normal individuals. Relatively few adverse effects are associated with its use in the treatment of depressed patients.
Serotonin precursors in the treatment of depression. [2013]5-HT precursors are used in depressions on the basis of the 5-HT hypothesis - an hypothesis which postulates that a cerebral 5-HT deficiency can play a role in the pathogenesis of depressions. This article presents a survey of the results obtained by this therapeutic strategy. There are strong indications that 5-HTP is of therapeutic value, particularly in the 5-HT-deficient subgroup of vital depressions. In the same subgroup, one controlled study has so far also shown a prophylatic 5-HTP effect. The effect of clomipramine is potentiated by 1-5-HTP, and this combination can give good results in therapy-resistant vital depressions. Other tricyclic compounds have not been studied in this context, nor have selective 5-HT reuptake inhibitors. The results of tryptophan studies are less unequivocal, possibly due to pharmacokinetic factors. Another possible explanation might be that, unlike 5-HTP research, tryptophan studies have so far disregarded the patient's serotonergic status. 5-HT research in depressions has also yielded the concept of the biochemical classifiability of depressions. This may become an important supplement to the conventional criteria of classification of depressions: symptomatology, etiology, and course.