NCT04395183CompletedPhase 2
5-HTP and Creatine for Depression
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2024
Brief summary (registry, in English)
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 + placebo, creatine + placebo, and 5-HTP + creatine, 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 15 May 2020
- Start date
- 1 Mar 2021
- Primary completion date
- 1 Aug 2023
- Lead sponsor
- University of Utah
- Diseases
- Depression
- NCT number
- NCT04395183
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 43
- From 1 Mar 2021 to the primary completion date, 1 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with an antipsychotic, mood stabilizer, or non-SSRI or SNRI antidepressant except for bupropion at FDA-approved doses or trazodone up to 200mg, or use of any supplements apart from standard multivitamins
- Previous diagnosis of serotonin syndrome or evidence of serotonin syndrome
- Contraindications to MRI: ferromagnetic implants, implanted devices, claustrophobia
Other illness
- Any non-MDD and non-anxiety psychiatric diagnosis, as identified by the SCID-5
- History of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease
- History of or current pulmonary disease
- History of fibromyalgia or any rheumatological condition
- History of or current seizure disorder
- Positive pregnancy test, pregnancy, failure to use adequate birth control method
Lab values
- History of cardiac disease or QTc \> 500ms
- Pre-existing eosinophilia (absolute eosinophil count \> 500/uL)
Other
- Current colitis or diverticulitis
- Current smoking
- Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
Who the study is looking for
- Adults age 25-40 years inclusive
- Current diagnosis of MDD identified by the SCID-5
- 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
Age in the registry: 25 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Utah Department of Psychiatry Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.