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

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00575328
First received: December 14, 2007
Last updated: June 10, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunction
Bipolar Disorder
Drug: Maca Root
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Reductions in ASEX and MGH-Sexual Dysfunction scores. [ Time Frame: Biweekly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: November 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. 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
Placebo Comparator: 2. Control
Subjects in this arm will receive placebo.
Drug: Placebo
Placebo provided by research pharmacy daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 (HAM-D < 10) and is without significant anxiety symptoms (HAM-A < 10). Her bipolar disorder must be in remission (YMRS < 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 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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575328

Locations
United States, Massachusetts
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Christina Dording, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Christina Dording, MD, Massachusetts General Hospital, Depression Clinical and Research Program
ClinicalTrials.gov Identifier: NCT00575328     History of Changes
Other Study ID Numbers: 2007-P-001471
Study First Received: December 14, 2007
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Sexual Dysfunction
Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Sexual Dysfunctions, Psychological
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on April 15, 2014