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

Completed · Phase 3 · Has a placebo group

Conditions studied: Antidepressant Induced Sexual Dysfunction

In brief

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.

Key facts

Study ID

NCT00568126

Run by

Massachusetts General Hospital

People needed

45

Starts

2007-12-27

Expected to finish

2010-10-05

Last updated by the study team

2020-08-26

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Depression Clinical and Research Program, Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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