CompletedNCT00181961Updated Aug 21, 2019Results posted

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

A Phase 3 interventional study of Maca Root in Depression and Sexual Dysfunction, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by Massachusetts General Hospital · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Depression
Sexual Dysfunction

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Keywords

antidepressant-induced sexual dysfunction

In context

Depression

8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 20 is below the median of 84 across 6,869 interventional studies indexed under Depression.

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Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

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Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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) and without significant anxiety symptoms (HAM-A\<10). These scales will rely on retrospective reporting from the participant.

Subjects must have had no sexual dysfunction prior to taking an antidepressant and there must be a clear temporal relationship between the sexual dysfunction and the antidepressant treatment. Sexual dysfunction occurring as a symptom of the depressive disorder for which the antidepressant treatment was initiated is not considered to be a pre-existing condition under this definition.

Subjects must meet at least one of the following criteria:
- Inability to have an orgasm (anorgasmia), according to patient opinion
- Clinically significant orgasm delay with masturbation or intercourse that according to patient opinion represents a meaningful delay and interferes with subject's sexual function compared with the subject's usual time to achieve orgasm in response to sexual stimulation prior to antidepressant medication
- Inability to attain or maintain until completion of sexual activity an adequate an erection or lubrication swelling response of sexual excitement that, according to patient opinion, interferes with subject's sexual function, compared to prior to antidepressant medication.
- Decreased libido according to patient opinion (and verified by objective measurements)
Subjects must experience at least one of the above criterion items with distress and or disability.
Subjects 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
Subjects must be in good general physical health

Exclusion criteria

Exclusion Criteria:

Primary or prior diagnosis of a sexual disorder (other than the side effect of the antidepressant drug or symptom of major depression)
Sexual dysfunction secondary to general underlying medical condition
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 their sexual dysfunction
Hamilton Depression and/or Anxiety Scale score (either) >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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 20 participants (actual)

Study arms

Experimental
Maca Root 1500mg
Patients receiving 1500mg of maca root
Drug: Maca Root
Experimental
Maca Root 3000mg
Patients receiving 3000mg of maca root
Drug: Maca Root

Interventions

DrugMaca Root

What researchers measure

Primary outcomes

Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores
Full title: Massachusetts General Hospital Sexual Dysfunction Inventory Minimum score for Men: 5 Minimum score for Women: 4 Maximum score for Men: 30 Maximum score for Women: 24 \*One item on the measure is for men only A score of a 5 (4 for women) indicates improvement in sexual function. A score of 10 (8 for women) indicates no change. A score higher than 10 (8 for women) indicates a level of sexual dysfunction.
Time frame: baseline to endpoint (8 weeks)

Results

Posted Aug 21, 2019

Participant flow

Participant flow — Overall Study
Milestone	Maca Root 1500mg	Maca Root 3000mg
Started	7	9
Completed	6	4
Not completed	1	5

Outcome measures

PrimaryChange in Massachusetts General Hospital Sexual Dysfunction Inventory Scores

Full title: Massachusetts General Hospital Sexual Dysfunction Inventory Minimum score for Men: 5 Minimum score for Women: 4 Maximum score for Men: 30 Maximum score for Women: 24 \*One item on the measure is for men only A score of a 5 (4 for women) indicates improvement in sexual function. A score of 10 (8 for women) indicates no change. A score higher than 10 (8 for women) indicates a level of sexual dysfunction.

Time frame:: baseline to endpoint (8 weeks)
Reported as:: Mean · score on a scale

Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores
score on a scale	Maca Root 1500mg	Maca Root 3000mg
Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores	.249 ± 2.39	.017 ± 1.15

Statistical analysis

Maca Root 1500mg vs Maca Root 3000mg · Wilcoxon (Mann-Whitney) · p = .016

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Maca Root 1500mg	—	0/7 (0%)	5/7 (71.4%)
Maca Root 3000mg	—	0/9 (0%)	7/9 (77.8%)

Most frequent other events

Most frequent other events
Event	Maca Root 1500mg	Maca Root 3000mg
GI UpsetGastrointestinal disorders	2/7	3/9
HeadacheGeneral disorders	0/7	2/9
IrritabilityGeneral disorders	1/7	1/9
Sleep issuesGeneral disorders	1/7	0/9
Fibromyalgia ExacerbationGeneral disorders	1/7	0/9
Urinary FrequencyGeneral disorders	0/7	1/9
Thicker Menstrual DischargeGeneral disorders	0/7	1/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Maca Root 1500mg	Maca Root 3000mg	Total
<=18 years	0	0	0
Between 18 and 65 years	7	9	16
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Maca Root 1500mg	Maca Root 3000mg	Total
Mean	39 ± 12	34 ± 15	36 ± 13

Sex: Female, Male
Sex: Female, Male(Participants)	Maca Root 1500mg	Maca Root 3000mg	Total
Female	6	8	14
Male	1	1	2

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Maca Root 1500mg	Maca Root 3000mg	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	7	9	16
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Maca Root 1500mg	Maca Root 3000mg	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	1	2
White	6	8	14
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Maca Root 1500mg	Maca Root 3000mg	Total
United States	7	9	16

Study locations

1 site

Massachusetts General Hospital
Boston, Massachusetts 02114, United States

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2007 to primary completion in Jun 2010, 30 months.

Results were first posted in Aug 2019, 9 years 2 months after primary completion.

Of 60 non-industry phase 3 interventional studies under Depression, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 53. This study's 30 months is close to that.

Counting every sponsor, half of 152 studies reached it within 27 months; a quarter within 21 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 13, 2005
First posted: Sep 16, 2005
StartActual: Dec 2007
Primary completionActual: Jun 2010
CompletionActual: Jun 2010
Results first posted: Aug 21, 2019
Last update: Aug 21, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00181961
Lead sponsor: Massachusetts General Hospital
Responsible party: Christina M. Dording, MD (MD, Massachusetts General Hospital) — Principal investigator
First posted: Sep 16, 2005
Start date: Dec 2007
Primary completion: Jun 2010
Completion: Jun 2010
Results posted: Aug 21, 2019
Last update: Aug 21, 2019

Study contacts

Christina M Dording, MD

principal investigator · Massachusetts General Hospital

View the source record on ClinicalTrials.gov ↗

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