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

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 106 participants

Interventions

• DRUG: Low Dose 5-hydroxytryptophan — 5-hydroxytryptophan 100mg PO BID
• DRUG: High Dose 5-hydroxytryptophan — 5-hydroxytryptophan 200mg PO BID
• DRUG: Low Dose Creatine Monohydrate — Creatine monohydrate 5g PO qday
• DRUG: High Dose Creatine Monohydrate — Creatine monohydrate 10g PO qday
• DRUG: Placebo — Creatine-matched placebo and 5-HTP-matched placebo; Placebo will be dextrose either encapsulated (5-HTP matched) or as loose powder (creatine matched)

Primary Outcomes

• 17-Item Hamilton Depression Rating Scale (8 weeks)

Secondary Outcomes

• Montgomery Asberg Depression Rating Scale (8 weeks)

Trial Locations

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

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