Phase 3
N=16
Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction
Depression · Sexual Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00181961 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores — .249; .017 score on a scale — p=.016
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Maca Root (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores |
.249; .017 | .016 sig |
Summary
The purpose of this study is to determine the dose of Maca Root effective for the treatment of antidepressant-induced sexual dysfunction in patients with DSM-IV defined Major Depressive Disorder. We propose to carry out a dose-finding pilot study to determine the minimum effective dose of Maca Root. We hypothesize that patients who receive Maca Root will experience alleviation of their sexual dysfunction, and this effect will be more pronounced in those who receive higher doses of maca root.
Eligibility Criteria
Inclusion Criteria
- Subjects have been taking an SSRI, venlafaxine, nefazodone, or tri/hetero cyclic antidepressant for treatment of depression for at least 8 weeks, are currently at a stable dose of the antidepressant for at least 4 weeks, and have been consistently experiencing arousal dysfunction (inability to attain or maintain an adequate lubrication/swelling response of sexual excitement until completion of sexual activity) or orgasmic dysfunction (delayed orgasm/anorgasmia following a normal sexual excitement phase) that interferes with sexual function for at least 4 weeks.
Subjects must currently be euthymic (HAM-D 10
- Blood pressure outside the range of 90/50 - 170/100
- Use of investigational drugs within prior 3 months or during study.
- Current use of other drugs for antidepressant induced sexual dysfunction or other therapies or medications to treat sexual dysfunction
- Hormone replacement therapy, unless patient has been on stable dose of hormone therapy for at least 3 months prior to the antidepressant treatment 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 of the screening physical examination
- History of elevated PSA levels that are greater than 0.2 (as defined by MGH labs)
- History of prostate or other hormonal cancers
- 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 not attempting some form of regular sexual activity at least twice monthly and at least once weekly during study visit intervals for the duration of the entire study
- Changes in antidepressant agent and/or dose of prescribed antidepressant agent.
Data sourced from ClinicalTrials.gov (NCT00181961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.