Study of Maca Root to Treat Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females
Condition: Sexual Dysfunction; Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Maca Root; Placebo
Intervention description: 3g/day of Maca Root for 12 weeks.; Placebo provided by research pharmacy daily for 12 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Maca root will be compared against inactive placebo as a treatment for sexual dysfunction induced by psychotropic drugs.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: All subjects, investigators, and clinical assessors were blinded to the intervention.
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Sexual Dysfunction; Bipolar Disorder

Summary:

      The purpose of this research study is to find out whether Maca Root is effective for treating
      sexual dysfunction in females that is caused by the treatment for bipolar disorder. 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. We suspect that Maca Root will result in a
      significant reduction in sexual dysfunction when compared to a placebo group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is female, age 18 to 80 years

          -  Subject has been on a steady regimen to treat bipolar disorder, including monotherapy
             with or any combination of antidepressants, mood stabilizers, atypical antipsychotics,
             or benzodiazepines, for at least 8 weeks; and is currently on a stable dose of that
             regimen for at least 4 weeks

          -  Subject is currently euthymic (Hamilton-D scale score < 10) and is without significant
             anxiety symptoms (Hamilton-A < 10). Her bipolar disorder must be in remission (Young
             Mania Rating Scale score < 10)

          -  Subject must have had no sexual dysfunction prior to taking psychotropic medications
             and there must be a clear temporal relationship between the sexual dysfunction and the
             treatment for bipolar disorder

          -  Subject must have been consistently experiencing at least one of the following
             criteria 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 adequate
             lubrication 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 bipolar
             treatment regimen and is willing to continue efforts at sexual activity at least once
             weekly 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 the
             bipolar 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 which
             are 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 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 bipolar treatment regimen and had no sexual dysfunction
             while on the same hormone therapy regimen, and there is no change in the hormone
             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 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 bipolar medication 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)