RightFit
RecruitingPhase 2

5-HTP and Creatine for Depression R33 Phase

31P-MRS and Resting State Functional Connectivity Analysis of the Effects of 5-hydroxytryptophan and Creatine for Antidepressant Augmentation in Patients With SSRI/SNRI-resistant Major Depressive Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Subjects will be randomized between 5-HTP 100mg BID + creatine 5g daily, 5-HTP 200mg BID + creatine 10g daily, vs double placebo, for 8 weeks."
  • "The ability of the interventions to affect biomarkers associated with depression will be assessed using brain phosphorus magnetic resonance spectroscopy, functional connectivity imaging, and plasma serotonin levels."
  • "Proton magnetic resonance spectroscopy (1H-MRS) shows that high-altitude residents have altered whole brain pH and reduced inorganic phosphate to total phosphate (tP) ratios compared to persons dwelling at sea-level."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This is a three-armed clinical trial examining the effect of 5-hydroxytryptophan and creatine monohydrate as augmenting agents for the treatment of depression. Subjects will be randomized between 5-HTP 100mg BID + creatine 5g daily, 5-HTP 200mg BID + creatine 10g daily, vs double placebo, for 8 weeks. The ability of the interventions to affect biomarkers associated with depression will be assessed using brain phosphorus magnetic resonance spectroscopy, functional connectivity imaging, and plasma serotonin levels.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Adults age 18-65 years inclusive * Current diagnosis of MDD identified by the MINI (Mini Neuropsychiatric Interview) * Current HAM-D17 score of \>= 16 * Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks * Right-handed * Residing at \> 4000 ft for at least 12 weeks Exclusion Criteria: * Any non-MDD and non-anxiety psychiatric diagnosis, as identified by the MINI * History of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease * Current colitis or diverticulitis * History of or current pulmonary disease (except well controlled asthma) * Current smoking * History of cardiac disease or QTc \> 500ms * History of fibromyalgia or any rheumatological condition * History of or current seizure disorder * Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale * Current treatment with an antipsychotic, mood stabilizer, or non-SSRI/SNRI antidepressant except for bupropion at FDA-approved doses or trazodone up to 200mg, or use of any supplements apart from standard multivitamins * Positive pregnancy test, pregnancy, failure to use adequate birth control method * Previous diagnosis of serotonin syndrome or evidence of serotonin syndrome * Pre-existing eosinophilia (absolute eosinophil count \> 500/uL) * Contraindications to MRI: ferromagnetic implants, implanted devices, claustrophobia

Study sites (1)

UT