drugset / Trial / NCT00181961

Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction

NCT00181961 ↗

Phase 3 Completed 20 enrolled Massachusetts General Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the dose of Maca Root effective for the treatment of antidepressant-induced sexual dysfunction in patients with DSM-IV defined Major Depressive Disorder. We propose to carry out a dose-finding pilot study to determine the minimum effective dose of Maca Root. We hypothesize that patients who receive Maca Root will experience alleviation of their sexual dysfunction, and this effect will be more pronounced in those who receive higher doses of maca root.

Timeline

Start
2007-12
Primary completion
2010-06
Completion
2010-06

Outcome

Met primary endpoint

registry analysis (superiority test); Maca Root 1500mg vs Maca Root 3000mg; p = .016; Wilcoxon (Mann-Whitney) NCT00181961 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Maca Root Unknown 1500 mg —
Subject Maca Root Unknown 3000 mg —