The purpose of this study is to find out whether Maca Root is effective for treating sexual dysfunction in females that is caused by antidepressant drugs. An additional aim of the study is to document the safety and tolerability of maca root, as well as any potential side effects that it causes.
This is a 12-week, double-blind, placebo-controlled trial comparing maca root (3.0 g/day) versus an inactive placebo in female outpatients with SSRI/SNRI-induced sexual dysfunction whose depression had remitted with SSRI treatment. Outcome measures include improvement in sexual functioning as per the Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States
Proportion of Participants in Remission Based on Arizona Sexual Experience Scale (ASEX) Score of 10 or Less After 12 Weeks of Treatment.
Arizona Sexual Experience Scale (ASEX) consists of five items rating sexual drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm.The range of total score is 5-30 with the higher scores indicating greater sexual dysfunction. A total final score of 10 or less is considered to indicate remission of sexual dysfunction.
Time frame: 12 weeks
Proportion of Participants in Remission Based on Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ) Score of 12 or Less After 12 Weeks of Treatment.
Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) is composed of five items evaluating libido, sexual arousal or excitement, ability to achieve orgasm, ability to achieve and maintain an erection (for men only) and overall sexual satisfaction. Items are rated on a scale of 1 to 6 with a rating of 1 indicating greater than normal functioning and a rating of 6 indicating totally absent functioning. A total final score of 12 or less is considered to indicate remission of sexual dysfunction.
Time frame: 12 weeks
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