DepressionPhase 3NCT00181961
Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction
A Phase 3 study testing Maca Root in people with Depression and Sexual Dysfunction, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Sexual Dysfunction
- What is being tested?
- Maca Root
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Dose-Finding Study of the Tolerability and Efficacy of Maca Root in Patients With Antidepressant-Induced Sexual Dysfunction
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
- Depression, Sexual Dysfunction
- Being tested
- Maca Root
- Keywords
- antidepressant-induced sexual dysfunction
- Medical subject headings
- Depression, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maca RootDrug
| Study group | Role | What they receive |
|---|---|---|
| Maca Root 1500mg | Experimental | Patients receiving 1500mg of maca root Receives: Drug: Maca Root |
| Maca Root 3000mg | Experimental | Patients receiving 3000mg of maca root Receives: Drug: Maca Root |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to endpoint (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina M. Dording, MD, Massachusetts General Hospital
- Investigators
- Christina M Dording, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181961
- Sponsor's protocol ID
- 2004-P-001269
- Status last verified
- Aug 2019
- First submitted
- 13 Sep 2005
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Finding Study of the Tolerability and Efficacy of Maca Root in Patients With Antidepressant-Induced Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT00181961
- Acronym / sponsor ID
- 2004-P-001269
- Conditions
- Depression, Sexual Dysfunction
- Keywords
- antidepressant-induced sexual dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2007 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 21 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maca Root 1500mg | Experimental | Drug: Maca RootPatients receiving 1500mg of maca root |
| Maca Root 3000mg | Experimental | Drug: Maca RootPatients receiving 3000mg of maca root |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Subjects must experience at least one of the above criterion items with distress and or disability.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maca Root | Drug | Maca Root 1500mg, Maca Root 3000mg |
Primary outcome
Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores
Time frame: baseline to endpoint (8 weeks)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina M Dording, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maca Root in people with Depression and Sexual Dysfunction, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Massachusetts General Hospital Sexual Dysfunction Inventory Scores (time frame: baseline to endpoint (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.