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

NCT00575328 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 2007-P-001471
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sexual Dysfunction; Bipolar Disorder

Keywords

Sexual Dysfunction; Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• Reductions in Arizona Sexual Experience Scale (ASEX) Scores Over 12 Weeks of Treatment.

  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.

  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

Study Arms (2)

Maca Root

EXPERIMENTAL

Subjects in this arm will be given 3g/day of Maca Root.

Drug: Maca Root

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive inactive placebo.

Drug: Placebo

Interventions

Maca Root DRUG

3g/day of Maca Root for 12 weeks.

Also known as: Lepidium

Maca Root

Placebo DRUG

Placebo provided by research pharmacy daily for 12 weeks.

Also known as: Inactive placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Bipolar Disorder

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Limitations and Caveats

Study was never completed due to low enrollment. Only 8 of a projected 80 subjects were randomized over a period of 2 years. Sample is too small to yield useful information.

Results Point of Contact

• Title: Dr. David Mischoulon, Director
• Organization: Depression Clinical and Research Program, Massachusetts General Hospital

dmischoulon@partners.org

617-724-5198

Study Officials

• Christina Dording, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• David Mischoulon, MD, PhD

  Massachusetts General Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All subjects, investigators, and clinical assessors were blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Maca root will be compared against inactive placebo as a treatment for sexual dysfunction induced by psychotropic drugs.

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: February 26, 2008
• Primary Completion: April 26, 2010
• Study Completion: April 26, 2010
• Last Updated: September 25, 2020
• Results First Posted: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)