Using 5-HTP and creatine to treat depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of 5-hydroxytryptophan (5-HTP) and creatine monohydrate as adjunct treatments for major depressive disorder (MDD). Participants will be randomly assigned to receive either low or high doses of 5-HTP combined with creatine or a placebo for 8 weeks. The study aims to assess the impact of these interventions on biomarkers related to depression through advanced imaging techniques and blood tests. The trial focuses on individuals living at high altitudes, where hypoxia may contribute to depressive symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Utah Department of Psychiatry
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Brent Kious, MD
• Email: brent.kious@hsc.utah.edu
• Phone: 8015851418

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dupilumab for Major Depressive Disorder

  This study tests whether dupilumab can engage immune targets in adults with major depressive disorder to see if it can help with depressive symptoms.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07908563

• Accelerated vs Standard iTBS for Major Depression

  This trial tests whether giving more accelerated iTBS sessions is better tolerated and more effective than the standard schedule for adults with major depressive disorder.

  Recruiting Military Hospital 175 · Ho Chi Minh City · NCT07768397

• Psilocybin with Structured Integrated Reframing Therapy for trauma-related MDD and PTSD

  This trial tests whether psilocybin therapy, alone or with Structured Integrated Reframing Therapy (SIRT), helps people with trauma-related major depressive disorder who are already on a stable antidepressant.

  Recruiting Phase 3 Khyber Medical University Peshawar · Islamabad, Capital and 2 other locations · NCT07703722

• Magnesium Bisglycinate Added to Your Depression Treatment

  This study tests whether adding magnesium bisglycinate to your current antidepressant can help reduce depressive symptoms and improve sleep and daily functioning for adults with major depressive disorder.

  Recruiting All India Institute of Medical Sciences, Bhubaneswar · Bhubaneswar, Odisha · NCT07633080

• Motif XCS System for treatment-resistant depression

  This study tests whether the Motif XCS System is safe and tolerable and might help people with treatment-resistant major depressive disorder.

  Recruiting at 4 sites Motif Neurotech, Inc. · Atlanta, Georgia and 3 other locations · NCT07594483

• A Phase 3 test of DT120 for major depressive disorder

  DT120 is tested against placebo in adults with major depressive disorder to see if it can help reduce depressive symptoms.

  Recruiting at 23 sites Phase 3 Definium Therapeutics US, Inc. · Little Rock, Arkansas and 25 other locations · NCT07592689

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.