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

September 5, 2020 updated by: David Mischoulon, MD, PhD, Massachusetts General Hospital

A Double-Blind, Placebo Controlled Study of Maca Root for the Treatment of Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study seeks to enroll 80 patients with sexual dysfunction associated with their bipolar medication regimen over 24 months. Subjects were outpatient females between 18 and 80 years old with no significant symptoms of mania (Young Mania Rating Scale score<10), and who have been on a steady regimen of medications to treat bipolar disorder for at least 8 weeks, with a stable dose for at least 4 weeks. Subjects will be randomly assigned in a double blind manner to receive 3000 mg/day of maca root or identical placebo for 12 weeks to determine whether maca root is more effective than placebo for the treatment of sexual dysfunction associated with treatment regimens for bipolar disorder.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Depression Clinical and Research Program, Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

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
  • 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
  • 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 bipolar medication 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Maca Root
Subjects in this arm will be given 3g/day of Maca Root.
Drug: Maca Root
3g/day of Maca Root for 12 weeks.
Other Names:
  • Lepidium
Placebo Comparator: Placebo
Subjects in this arm will receive inactive placebo.
Drug: Placebo
Placebo provided by research pharmacy daily for 12 weeks.
Other Names:
  • Inactive placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment.
Time Frame: Biweekly from Baseline (week zero) to 12 weeks
The ASEX scale 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 from 5-30, with the higher scores indicating greater sexual dysfunction. Scores were obtained at baseline and at all biweekly assessment visits over the 12 weeks of treatment.
Biweekly from Baseline (week zero) to 12 weeks
Reductions in Massachusetts General Hospital Sexual Dysfunction (MGH-SD) Inventory Scores Over 12 Weeks of Treatment.
Time Frame: Biweekly from Baseline (week zero) to 12 weeks
This instrument 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. Possible total scores range from 5-30, with higher scores indicating greater pathology. Scores were obtained at baseline and at each biweekly assessment visit over 12 weeks of treatment.
Biweekly from Baseline (week zero) to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Alliance for Research on Schizophrenia and Depression

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christina Dording, MD, Massachusetts General Hospital
  • Study Director: David Mischoulon, MD, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007-P-001471

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan for data sharing at this time. Study was never completed and did not have enough subjects to yield useful data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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