Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females
Condition: Antidepressant Induced Sexual Dysfunction
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: Subjects were randomized in a double blind manner to maca root or placebo. Improvement in sexual functioning was compared between the two treatment groups.
Masking: Double (Participant, Investigator)
Masking description: Study subjects and investigator clinicians were blinded to the treatment assignment.
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Antidepressant Induced Sexual Dysfunction; Depression; Sexual Dysfunction

Summary:

      The purpose of this study is to find out whether Maca Root is effective for treating sexual
      dysfunction in females that is caused by antidepressant drugs. 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.
    

Eligibility criteria:

        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) and is without significant anxiety symptoms
             (HAM-A < 10)

          -  Subject must have had no sexual dysfunction prior to taking antidepressant and there
             must be a clear temporal relationship between the sexual dysfunction and the
             antidepressant treatment

          -  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
             antidepressant treatment and are 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

          -  Hamilton Depression and/or Anxiety Scale score (either) > 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)