Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction
Condition: Depression; Sexual Dysfunction
MeSH terms: Depression
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The purpose of this study is to determine whether Maca Root is effective for the treatment of
      antidepressant-induced sexual dysfunction, and to further determine whether higher doses of
      Maca Root powder would be more effective than lower doses in reducing the symptoms of
      antidepressant-induced sexual dysfunction. An additional aim of the study is to document the
      safety and tolerability of Maca Root, which could be particularly helpful in treating
      antidepressant-induced sexual dysfunction in elderly and cardiac-impaired populations taking
      oral nitrates who may not be eligible for treatment with the current oral phosphodiesterase
      inhibitors.

      Subjects will be randomized into two arms of 10 for this 12-week study. The study will be
      double blind with regard to doses received. Ten subjects will receive 1500mg/day of maca for
      the 12-week period and the other 10 subjects will receive 3000mg/day of maca per day for the
      12-week study period. Patients will be seen every other week. There is no placebo arm.

      At the final study visit, week 12, subjects will be evaluated to see if their sexual function
      has returned.

      After careful review of the literature we have found that there are very few studies that
      have evaluated Maca Root in humans. However the one very relevant study completed by Gonzalez
      and colleagues looked at doses of 1500 and 3000mg in men and found there were increased
      sexual interests on both doses. Thus, since this is a dose-finding study we believe this dose
      is an appropriate place to begin.

      Hypotheses A:

      The response rate will be higher for the high-dose maca group compared to the low-dose group;
      and this response will be comparable to the 50-85% reported with sildenafil.

      Hypothesis B:

      There will be a statistically significant difference in the magnitude of response between the
      two testing conditions, as measured by a decrease in baseline sexual dysfunction scores. The
      reduction in sexual dysfunction scores will be greater in the high-dose maca group than in
      the low-dose maca group.
    

Intervention name(s): Maca Root
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: antidepressant-induced sexual dysfunction