Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction

2014-08-27 03:50:26 | BioPortfolio


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.


The purpose of this study is to determine whether Maca Root is effective for the treatment of antidepressant-induced sexual dysfunction, and to further determine whether higher doses of Maca Root powder would be more effective than lower doses in reducing the symptoms of antidepressant-induced sexual dysfunction. An additional aim of the study is to document the safety and tolerability of Maca Root, which could be particularly helpful in treating antidepressant-induced sexual dysfunction in elderly and cardiac-impaired populations taking oral nitrates who may not be eligible for treatment with the current oral phosphodiesterase inhibitors.

Subjects will be randomized into two arms of 10 for this 12-week study. The study will be double blind with regard to doses received. Ten subjects will receive 1500mg/day of maca for the 12-week period and the other 10 subjects will receive 3000mg/day of maca per day for the 12-week study period. Patients will be seen every other week. There is no placebo arm.

At the final study visit, week 12, subjects will be evaluated to see if their sexual function has returned.

After careful review of the literature we have found that there are very few studies that have evaluated Maca Root in humans. However the one very relevant study completed by Gonzalez and colleagues looked at doses of 1500 and 3000mg in men and found there were increased sexual interests on both doses. Thus, since this is a dose-finding study we believe this dose is an appropriate place to begin.

Hypotheses A:

The response rate will be higher for the high-dose maca group compared to the low-dose group; and this response will be comparable to the 50-85% reported with sildenafil.

Hypothesis B:

There will be a statistically significant difference in the magnitude of response between the two testing conditions, as measured by a decrease in baseline sexual dysfunction scores. The reduction in sexual dysfunction scores will be greater in the high-dose maca group than in the low-dose maca group.

Study Design

Allocation: Randomized, Control: Dose Comparison, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment




Maca Root


Massachusetts General Hospital
United States


Active, not recruiting


Massachusetts General Hospital

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:50:26-0400

Clinical Trials [786 Associated Clinical Trials listed on BioPortfolio]

Study of Maca Root to Treat 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 additio...

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

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...

A Study With Arctic Root Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, i

This is clinical trial to document the efficacy of a proprietary standardized extract of Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an every...

Accuracy of Electronic Apex Locators ProMark, RootZX II and NRG Rider on Working Length of Multi-rooted Teeth

The purpose of this study is to compare the accuracy of different apex locators. Before root canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the roo...

Study of Scaling and Root Planing With PerioWave Versus Scaling and Root Planing Alone in Chronic Periodontitis

This study is to determine whether scaling and root planing (SRP) followed by photodynamic disinfection results in improved outcomes that persist over time in adults with chronic periodont...

PubMed Articles [3800 Associated PubMed Articles listed on BioPortfolio]

More nerve root injuries occur with minimally invasive lumbar surgery: Let's tell someone.

In a recent study entitled: "More nerve root injuries occur with minimally invasive lumbar surgery, especially extreme lateral interbody fusion (XLIF): A review", Epstein documented that more nerve ro...

Arabidopsis: An Adequate Model for Dicot Root Systems?

The Arabidopsis root system is frequently considered to have only three classes of root: primary, lateral, and adventitious. Research with other plant species has suggested up to eight different devel...

Root Tip Recovery via Root Canal Instrumentation.

This article reviews 2 representative cases of root tip recovery by root canal instrumentation. Recommendations associated with the use of root canal instrumentation for root tip recovery within mandi...

Measurement of root surface area of permanent teeth with root variations in a Chinese population-A micro-CT analysis.

This study investigated the influence of root variations on the root surface area (RSA) by using micro-CT scans.

A Cone-Beam Computed Tomographic Study on Mandibular First Molars in a Chinese Subpopulation.

The purpose of this study was to conduct a cone-beam computed tomographic (CBCT) investigation on the root and canal configuration of the mandibular first molars, especially the morphology of the dist...

Medical and Biotech [MESH] Definitions

A plant genus of the family BRASSICACEAE growing in Peru mountains. It is the source of maca root.

Decompression external to the body, most often the slow lessening of external pressure on the whole body (especially in caisson workers, deep sea divers, and persons who ascend to great heights) to prevent DECOMPRESSION SICKNESS. It includes also sudden accidental decompression, but not surgical (local) decompression or decompression applied through body openings.

Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. (From DSM-IV, p386)

Depressive states usually of moderate intensity in contrast with major depression present in neurotic and psychotic disorders.

The part of a tooth from the neck to the apex, embedded in the alveolar process and covered with cementum. A root may be single or divided into several branches, usually identified by their relative position, e.g., lingual root or buccal root. Single-rooted teeth include mandibular first and second premolars and the maxillary second premolar teeth. The maxillary first premolar has two roots in most cases. Maxillary molars have three roots. (Jablonski, Dictionary of Dentistry, 1992, p690)

More From BioPortfolio on "Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction"

Quick Search

Relevant Topics

Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Bipolar Disorders
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Over half of Bipolar cases develops before the age of 25. Bipolar ...

Searches Linking to this Trial