Study of Maca Root to Treat Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Sexual Dysfunction, Bipolar Disorder

In brief

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.

Key facts

Study ID: NCT00575328
Run by: Massachusetts General Hospital
People needed: 8
Starts: 2008-02-26
Expected to finish: 2010-04-26
Last updated by the study team: 2020-09-25

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 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

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
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

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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