Antidepressant Induced Sexual DysfunctionPhase 3NCT00568126
Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females
A Phase 3 study testing Maca Root in people with Antidepressant Induced Sexual Dysfunction, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Antidepressant Induced Sexual Dysfunction
- What is being tested?
- Maca Root
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2007to 5 Oct 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Any clinically significant abnormality on the screening physical examination
- History of hormonal cancers
- Any medical or psychological condition or social circumstances that would impair subject's ability to participate reliably in the study, or that may increase the risk to subjects or others as a result of participating in this study
- Dyspareunia secondary to an inflammatory or anatomical condition
- 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 who do not understand and communicate in English
- Subjects for whom sexual activity is inadvisable
- Subjects whose sexual dysfunction is considered to be situational
- Subjects not attempting some form of regular sexual activity at least twice monthly and at least once weekly during study visit intervals for duration of entire study
- Changes in antidepressant agent and/or dose of medication within the last 4 weeks before baseline visit
- Participants on medications with a narrow therapeutic window or low therapeutic index for which small variations may be harmful given the lack of systematic experience with drug-supplement interactions (i.e. - cyclosporine, digoxin, warfarin, and antiretrovirals)
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Double-Blind, Placebo Controlled 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 to document the safety and tolerability of maca root, as well as any potential side effects that it causes.
Read the detailed description
This is a 12-week, double-blind, placebo-controlled trial comparing maca root (3.0 g/day) versus an inactive placebo in female outpatients with SSRI/SNRI-induced sexual dysfunction whose depression had remitted with SSRI treatment. Outcome measures include improvement in sexual functioning as per the Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ).
- Being tested
- Maca Root, Placebo
- Keywords
- Antidepressant Induced Sexual Dysfunction, Depression, 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
Also called Lepidium
3g/day of Maca Root for 12 weeks.
PlaceboDrug
Also called Inactive placebo
Placebo provided by research pharmacy daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Maca Root | Experimental | Subjects in this arm will be given 3g/day of maca root for 12 weeks Receives: Drug: Maca Root |
| Placebo | Placebo comparator | Subjects in this arm will receive inactive placebo for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study start27 Dec 2007
- Primary completion5 Oct 2010
- Study completion5 Oct 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antidepressant Induced Sexual DysfunctionStudies 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
- Model description
- Subjects were randomized in a double blind manner to maca root or placebo. Improvement in sexual functioning was compared between the two treatment groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH), A Healthy Alternative, LLC
- Responsible party
- Principal investigator, David Mischoulon, MD, PhD, Massachusetts General Hospital
- Investigators
- Christina Dording, MD, Principal investigator, Massachusetts General HospitalDavid Mischoulon, MD, PhD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568126
- Sponsor's protocol ID
- 2007P001090
- Other IDs
- R21AT004385
- Status last verified
- Aug 2020
- First submitted
- 3 Dec 2007
- Last updated
- 26 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan for this. In the event that other researchers inquire about using our data (e.g. in a meta-analysis), we will evaluate how to proceed.
Publications
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.
PubMed 25954318
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo Controlled Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females
- ClinicalTrials.gov ID
- NCT00568126
- Acronym / sponsor ID
- 2007P001090
- Keywords
- Antidepressant Induced Sexual Dysfunction, Depression, Sexual Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH), A Healthy Alternative, LLC
- Study start
- 27 Dec 2007 (actual)
- Primary completion
- 5 Oct 2010 (actual)
- Study completion
- 5 Oct 2010 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Posted 26 Aug 2020
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 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.
Detailed description
This is a 12-week, double-blind, placebo-controlled trial comparing maca root (3.0 g/day) versus an inactive placebo in female outpatients with SSRI/SNRI-induced sexual dysfunction whose depression had remitted with SSRI treatment. Outcome measures include improvement in sexual functioning as per the Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects were randomized in a double blind manner to maca root or placebo. Improvement in sexual functioning was compared between the two treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Maca Root | Experimental | Drug: Maca RootSubjects in this arm will be given 3g/day of maca root for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboSubjects in this arm will receive inactive placebo for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (29 listed)
- 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
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 RootAlso: Lepidium3g/day of Maca Root for 12 weeks. | Drug | Maca Root |
| PlaceboAlso: Inactive placeboPlacebo provided by research pharmacy daily for 12 weeks. | Drug | Placebo |
Primary outcome
Proportion of Participants in Remission Based on Arizona Sexual Experience Scale (ASEX) Score of 10 or Less After 12 Weeks of Treatment.
Time frame: 12 weeks
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.
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.
Time frame: 12 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25954318Dording 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.
- Individual participant dataSharing planned: No. No current plan for this. In the event that other researchers inquire about using our data (e.g. in a meta-analysis), we will evaluate how to proceed.
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 Dording, MD principal investigator
Massachusetts General Hospital
David Mischoulon, MD, PhD study director
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 Antidepressant Induced 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 13 inclusion and 29 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 26 Aug 2020. 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. Some participants in this study may receive a placebo. 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 26 Aug 2020). 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?
Proportion of Participants in Remission Based on Arizona Sexual Experience Scale (ASEX) Score of 10 or Less After 12 Weeks of Treatment. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00568126, which also lists 1 linked publication.
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 26 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.