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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Utah
University of Utah Department of Psychiatry
RECRUITING
Salt Lake City
Contact Information
Primary
Brent Kious, MD
brent.kious@hsc.utah.edu
8015851418
Backup
Hailey Nielson, MS
hailey.nielson@utah.edu
801-581-3475
Time Frame
Start Date: 2023-09-28
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 106
Treatments
Experimental: Low Dose 5-hydroxytryptophan and Creatine Monohydrate
5-HTP 100mg PO BID plus creatine 5g PO Qday
Experimental: High Dose 5-hydroxytryptophan and Creatine Monohydrate
5-HTP 200mg PO BID plus creatine 10mg PO Qday
Placebo_comparator: Double Placebo
Creatine-matched placebo and 5-HTP-matched placebo
Related Therapeutic Areas
Sponsors
Leads: University of Utah

This content was sourced from clinicaltrials.gov