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

NCT00568126 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2007P001090R21AT004385
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antidepressant Induced Sexual Dysfunction

Keywords

Antidepressant Induced Sexual Dysfunction; Depression; Sexual Dysfunction

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants in Remission Based on Arizona Sexual Experience Scale (ASEX) Score of 10 or Less After 12 Weeks of Treatment.

  Arizona Sexual Experience Scale (ASEX) 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 5-30 with the higher scores indicating greater sexual dysfunction. A total final score of 10 or less is considered to indicate remission of sexual dysfunction.

  12 weeks

• Proportion of Participants in Remission Based on Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ) Score of 12 or Less After 12 Weeks of Treatment.

  Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) 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. A total final score of 12 or less is considered to indicate remission of sexual dysfunction.

  12 weeks

Study Arms (2)

Maca Root

EXPERIMENTAL

Subjects in this arm will be given 3g/day of maca root for 12 weeks

Drug: Maca Root

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive inactive placebo for 12 weeks.

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 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• A Healthy Alternative, LLC: collaborator

Study Sites (1)

Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Dording CM, Schettler PJ, Dalton ED, Parkin SR, Walker RS, Fehling KB, Fava M, Mischoulon D. A double-blind placebo-controlled trial of maca root as treatment for antidepressant-induced sexual dysfunction in women. Evid Based Complement Alternat Med. 2015;2015:949036. doi: 10.1155/2015/949036. Epub 2015 Apr 14.

  PMID: 25954318 RESULT

MeSH Terms

Conditions

Depression; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Genital Diseases; Urogenital Diseases

Limitations and Caveats

1\. Small sample. Reliance on patient self-report in domain of orgasm (subjective and subject to bias/inaccuracy). 2. No liver function tests (LFTs) obtained; some herbal extracts may induce LFT elevation, though there is no such evidence for maca.

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study subjects and investigator clinicians were blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Subjects were randomized in a double blind manner to maca root or placebo. Improvement in sexual functioning was compared between the two treatment groups.

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: December 27, 2007
• Primary Completion: October 5, 2010
• Study Completion: October 5, 2010
• Last Updated: August 26, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)