Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction
Condition: Depression; Sexual Dysfunction
MeSH terms: Depression
Intervention: Maca Root
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: antidepressant-induced sexual dysfunction

Summary:

      The purpose of this study is to determine the dose of Maca Root effective for the treatment
      of antidepressant-induced sexual dysfunction in patients with DSM-IV defined Major Depressive
      Disorder. We propose to carry out a dose-finding pilot study to determine the minimum
      effective dose of Maca Root. We hypothesize that patients who receive Maca Root will
      experience alleviation of their sexual dysfunction, and this effect will be more pronounced
      in those who receive higher doses of maca root.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects have been taking an SSRI, venlafaxine, nefazodone, or tri/hetero cyclic
             antidepressant for treatment of depression for at least 8 weeks, are currently at a
             stable dose of the antidepressant for at least 4 weeks, and have been consistently
             experiencing arousal dysfunction (inability to attain or maintain an adequate
             lubrication/swelling response of sexual excitement until completion of sexual
             activity) or orgasmic dysfunction (delayed orgasm/anorgasmia following a normal sexual
             excitement 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 there
        must be a clear temporal relationship between the sexual dysfunction and the antidepressant
        treatment. Sexual dysfunction occurring as a symptom of the depressive disorder for which
        the antidepressant treatment was initiated is not considered to be a pre-existing condition
        under 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 that
                  according to patient opinion represents a meaningful delay and interferes with
                  subject's sexual function compared with the subject's usual time to achieve
                  orgasm in response to sexual stimulation prior to antidepressant medication

               -  Inability to attain or maintain until completion of sexual activity an adequate
                  an erection or lubrication swelling response of sexual excitement that, according
                  to patient opinion, interferes with subject's sexual function, compared to prior
                  to antidepressant medication.

               -  Decreased libido according to patient opinion (and verified by objective
                  measurements)

          -  Subjects must experience at least one of the above criterion items with distress and
             or 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 the
             antidepressant treatment and are willing to continue efforts at sexual activity at
             least 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 the
             antidepressant 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 which
             are 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 other
             therapies or medications to treat sexual dysfunction

          -  Hormone replacement therapy, unless patient has been on stable dose of hormone therapy
             for at least 3 months prior to the antidepressant treatment 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 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 for
             sexual dysfunction

          -  Receiving psychosexual or other therapy for sexual dysfunction and not willing to
             discontinue that treatment at screening

          -  Subjects not attempting some form of regular sexual activity at least twice monthly
             and at least once weekly during study visit intervals for the duration of the entire
             study

          -  Changes in antidepressant agent and/or dose of prescribed antidepressant agent.