Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction
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|ClinicalTrials.gov Identifier: NCT00181961|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression Sexual Dysfunction||Drug: Maca Root||Phase 3|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Dose-Finding Study of the Tolerability and Efficacy of Maca Root in Patients With Antidepressant-Induced Sexual Dysfunction|
|Actual Study Start Date :||December 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Experimental: Maca Root 1500mg
Patients receiving 1500mg of maca root
Drug: Maca Root
Experimental: Maca Root 3000mg
Patients receiving 3000mg of maca root
Drug: Maca Root
- Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores [ Time Frame: baseline to endpoint (8 weeks) ]
Full title: Massachusetts General Hospital Sexual Dysfunction Inventory Minimum score for Men: 5 Minimum score for Women: 4 Maximum score for Men: 30 Maximum score for Women: 24
*One item on the measure is for men only
A score of a 5 (4 for women) indicates improvement in sexual function. A score of 10 (8 for women) indicates no change. A score higher than 10 (8 for women) indicates a level of sexual dysfunction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181961
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Christina M Dording, MD||Massachusetts General Hospital|