CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
Maca Rootdrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Taking an SSRI, venlafaxine, nefazodone, or tri/hetercyclic antidepressant for depression for ≥8 weeks at stable dose for ≥4 weeks
  • ✓Experiencing arousal dysfunction (inadequate lubrication/swelling response) or orgasmic dysfunction (delayed orgasm/anorgasmia) interfering with sexual function for ≥4 weeks
  • ✓Currently euthymic with HAM-D <10 and HAM-A <10
  • ✓Sexual dysfunction did not exist prior to antidepressant; clear temporal relationship between dysfunction and antidepressant treatment
Key exclusion· 16
  • ✕Primary or prior diagnosis of sexual disorder (other than antidepressant side effect or depression symptom)
  • ✕Sexual dysfunction secondary to underlying medical condition
  • ✕Uncontrolled psychiatric disorder
  • ✕Alcohol or substance abuse/dependence within past 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00181961
NCT00181961Phase 3Completed
CompareCT.gov

A Dose-Finding Study of the Tolerability and Efficacy of Maca Root in Patients With Antidepressant-Induced Sexual Dysfunction

Massachusetts General Hospital·interventional·Posted Sep 16, 2005·Updated Aug 21, 2019

In Brief

A Phase 3 clinical trial evaluating Maca Root for Depression and Sexual Dysfunction. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Sexual Dysfunction
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartDec 1, 2007
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.8 years ago

Interventions

Maca Rootdrug