Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females

Phase 3

Completed

Conditions: Antidepressant Induced Sexual Dysfunction

Interventions: Drug: Maca Root
Drug: Placebo

Registration Number: NCT00568126

Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description: This is a 12-week, double-blind, placebo-controlled trial comparing maca root (3.0 g/day) versus an inactive placebo in female outpatients with SSRI/SNRI-induced sexual dysfunction whose depression had remitted with SSRI treatment. Outcome measures include improvement in sexual functioning as per the Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 45

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maca Root	Maca Root	Subjects in this arm will be given 3g/day of maca root for 12 weeks
Placebo	Placebo	Subjects in this arm will receive inactive placebo for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants in Remission Based on Arizona Sexual Experience Scale (ASEX) Score of 10 or Less After 12 Weeks of Treatment.	12 weeks	Arizona Sexual Experience Scale (ASEX) consists of five items rating sexual drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm.The range of total score is 5-30 with the higher scores indicating greater sexual dysfunction. A total final score of 10 or less is considered to indicate remission of sexual dysfunction.
Proportion of Participants in Remission Based on Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ) Score of 12 or Less After 12 Weeks of Treatment.	12 weeks	Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) is composed of five items evaluating libido, sexual arousal or excitement, ability to achieve orgasm, ability to achieve and maintain an erection (for men only) and overall sexual satisfaction. Items are rated on a scale of 1 to 6 with a rating of 1 indicating greater than normal functioning and a rating of 6 indicating totally absent functioning. A total final score of 12 or less is considered to indicate remission of sexual dysfunction.

Secondary Outcome Measures