Study of Maca Root to Treat Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females

Inclusion Criteria:

• Subject is female, age 18 to 80 years

• Subject has been on a steady regimen to treat bipolar disorder, including monotherapywith or any combination of antidepressants, mood stabilizers, atypical antipsychotics,or benzodiazepines, for at least 8 weeks; and is currently on a stable dose of thatregimen for at least 4 weeks

• Subject is currently euthymic (Hamilton-D scale score < 10) and is without significantanxiety symptoms (Hamilton-A < 10). Her bipolar disorder must be in remission (YoungMania Rating Scale score < 10)

• Subject must have had no sexual dysfunction prior to taking psychotropic medicationsand there must be a clear temporal relationship between the sexual dysfunction and thetreatment for bipolar disorder

• Subject must have been consistently experiencing at least one of the followingcriteria for at least 4 weeks, with distress or disability:

• Inability to have an orgasm, according to patient opinion

• Clinically significant orgasm delay with masturbation or intercourse

• Inability to attain or maintain until completion of sexual activity an adequatelubrication swelling response of sexual excitement

• Decreased libido according to patient opinion

• Subject must be having or had been having some form of regular sexual activity (masturbation, oral sex, intercourse) at least twice monthly prior to the bipolartreatment regimen and is willing to continue efforts at sexual activity at least onceweekly for the duration of the study

• Subject must be in good general physical health

• Subject must be able to understand and communicate in English

• Subject must have given informed consent to participate in the study

Exclusion Criteria:

• Primary or prior diagnosis of a sexual disorder (other than the side effect of thebipolar medication or symptom of the bipolar disorder)

• Sexual dysfunction secondary to general underlying medical condition

• Penile, vaginal, clitoral or other sexual organ anatomical deformities

• 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 her sexual dysfunction

• 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 sexual dysfunction or other therapies or medications totreat sexual dysfunction

• Current use of nefazodone

• Hormone replacement therapy, unless patient has been on stable dose of hormone therapyfor at least 3 mo prior to the bipolar treatment regimen and had no sexual dysfunctionwhile on the same hormone therapy regimen, and there is no change in the hormonereplacement 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 on the screening physical examination

• History of hormonal cancers

• Any medical or psychological condition or social circumstances that would impairsubject's ability to participate reliably in the study, or that may increase the riskto 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 forsexual dysfunction

• Receiving psychosexual or other therapy for sexual dysfunction and not willing todiscontinue 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 monthlyand at least once weekly during study visit intervals for duration of entire study

• Changes in bipolar medication and/or dose of medication within the last 4 weeks beforebaseline visit

• Participants on medications with a narrow therapeutic window or low therapeutic indexfor which small variations may be harmful given the lack of systematic experience withdrug-supplement interactions (i.e. - cyclosporine, digoxin, warfarin, andantiretrovirals)