Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction

Inclusion Criteria:

• Subjects have been taking an SSRI, venlafaxine, nefazodone, or tri/hetero cyclicantidepressant for treatment of depression for at least 8 weeks, are currently at astable dose of the antidepressant for at least 4 weeks, and have been consistentlyexperiencing arousal dysfunction (inability to attain or maintain an adequatelubrication/swelling response of sexual excitement until completion of sexualactivity) or orgasmic dysfunction (delayed orgasm/anorgasmia following a normal sexualexcitement phase) that interferes with sexual function for at least 4 weeks. Subjects must currently be euthymic (HAM-D< 10) and without significant anxiety symptoms (HAM-A<10). These scales will rely on retrospective reporting from the participant. Subjects must have had no sexual dysfunction prior to taking an antidepressant and theremust be a clear temporal relationship between the sexual dysfunction and the antidepressanttreatment. Sexual dysfunction occurring as a symptom of the depressive disorder for whichthe antidepressant treatment was initiated is not considered to be a pre-existing conditionunder this definition.

• Subjects must meet at least one of the following criteria:

• Inability to have an orgasm (anorgasmia), according to patient opinion

• Clinically significant orgasm delay with masturbation or intercourse thataccording to patient opinion represents a meaningful delay and interferes withsubject's sexual function compared with the subject's usual time to achieveorgasm in response to sexual stimulation prior to antidepressant medication

• Inability to attain or maintain until completion of sexual activity an adequatean erection or lubrication swelling response of sexual excitement that, accordingto patient opinion, interferes with subject's sexual function, compared to priorto antidepressant medication.

• Decreased libido according to patient opinion (and verified by objectivemeasurements)

• Subjects must experience at least one of the above criterion items with distress andor disability.

• Subjects must be having or had been having some form of regular sexual activity (masturbation, oral sex, intercourse) at least twice monthly prior to theantidepressant treatment and are willing to continue efforts at sexual activity atleast once weekly for the duration of the study

• Subjects must be in good general physical health

Exclusion Criteria:

• Primary or prior diagnosis of a sexual disorder (other than the side effect of theantidepressant drug or symptom of major depression)

• Sexual dysfunction secondary to general underlying medical condition

• Any uncontrolled psychiatric disorder

• Alcohol or substance abuse or dependence within the past six months

• Recent major relationship changes, disruption, or turmoil ongoing or anticipated whichare unrelated to their sexual dysfunction

• Hamilton Depression and/or Anxiety Scale score (either) >10

• Blood pressure outside the range of 90/50 - 170/100

• Use of investigational drugs within prior 3 months or during study.

• Current use of other drugs for antidepressant induced sexual dysfunction or othertherapies or medications to treat sexual dysfunction

• Hormone replacement therapy, unless patient has been on stable dose of hormone therapyfor at least 3 months prior to the antidepressant treatment and had no sexualdysfunction while on the same hormone therapy regimen, and there is no change in thehormone replacement therapy 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 judgedunreliable to use an acceptable and verifiable form of contraception during the study

• Any clinically significant abnormality of the screening physical examination

• History of elevated PSA levels that are greater than 0.2 (as defined by MGH labs)

• History of prostate or other hormonal cancers

• 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 forsexual dysfunction

• Receiving psychosexual or other therapy for sexual dysfunction and not willing todiscontinue that treatment at screening

• Subjects not attempting some form of regular sexual activity at least twice monthlyand at least once weekly during study visit intervals for the duration of the entirestudy

• Changes in antidepressant agent and/or dose of prescribed antidepressant agent.