drugset / Trial / NCT02922725

Placebo-controlled Trial of 5-hydroxytryptophan and Creatine for SSRI or SNRI Augmentation in Treatment Resistant Depression in Females

NCT02922725

Phase 4 Terminated 32 enrolled Brent Michael Kious, MD, PhD
RandomizedParallel-groupTriple-blindTreatment

Summary

The investigators propose to determine if 8 weeks of dietary augmentation with oral 5g creatine monohydrate daily and 100 mg of 5-hydroxytryptophan (5-HTP) twice daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI- or SNRI-resistant depression, combined with the examination of changes in functional connectivity based on resting-state fMRI and changes in brain metabolism inferred from phosphorus-31 magnetic resonance spectroscopy.

Timeline

Start
2016-11
Primary completion
2020-05
Completion
2020-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator 5-Hydroxytryptophan Other / unclassified 100 mg
Comparator Creatine Other / unclassified 5 g Oral