Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females

Inclusion Criteria

• Subject is female, age 18 to 80 years
• Subject has been taking an SSRI, venlafaxine, or tri/heterocyclic antidepressant for the treatment of depression for at least 8 weeks; and is currently on a stable dose of the antidepressant for at least 4 weeks
• Subject is currently euthymic (HAM-D 10
• Blood pressure outside the range of 90/50 - 170/100
• Known hyperprolactinemia
• Use of investigational drugs within previous 3 months or during study
• Current use of other drugs for antidepressant induced sexual dysfunction or other therapies or medications to treat sexual dysfunction
• Current use of nefazodone
• Hormone replacement therapy, unless patient has been on stable dose of hormone therapy for at least 3 mo prior to the antidepressant treatment and had no sexual dysfunction while on the same hormone therapy regimen, and there is no change in the HRT during the study
• Pregnancy, lactating, or planning to become pregnant during the study
• Child bearing potential subjects unwilling and/or not prepared and/or who are judged unreliable to use an acceptable and verifiable form of contraception during the study
• Any clinically significant abnormality on the screening physical examination
• History of hormonal cancers
• Any medical or psychological condition or social circumstances that would impair subject's ability to participate reliably in the study, or that may increase the risk to subjects or others as a result of participating in this study
• Dyspareunia secondary to an inflammatory or anatomical condition
• Prior use of maca for at least two weeks
• Infection of the urogenital tract that may make sexual activity painful or difficult
• Subjects whose sexual partners are suffering from and/or receiving treatment for sexual dysfunction
• Receiving psychosexual or other therapy for sexual dysfunction and not willing to discontinue that treatment at screening
• Subjects who do not understand and communicate in English
• Subjects for whom sexual activity is inadvisable
• Subjects whose sexual dysfunction is considered to be situational
• Subjects not attempting some form of regular sexual activity at least twice monthly and at least once weekly during study visit intervals for duration of entire study
• Changes in antidepressant agent and/or dose of medication within the last 4 weeks before baseline visit
• Participants on medications with a narrow therapeutic window or low therapeutic index for which small variations may be harmful given the lack of systematic experience with drug-supplement interactions (i.e. - cyclosporine, digoxin, warfarin, and antiretrovirals)