Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females
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|ClinicalTrials.gov Identifier: NCT00568126|
Recruitment Status : Completed
First Posted : December 5, 2007
Results First Posted : August 26, 2020
Last Update Posted : August 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Antidepressant Induced Sexual Dysfunction||Drug: Maca Root Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Investigator)|
|Masking Description:||Study subjects and investigator clinicians were blinded to the treatment assignment.|
|Official Title:||A Double-Blind, Placebo Controlled Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females|
|Actual Study Start Date :||December 27, 2007|
|Actual Primary Completion Date :||October 5, 2010|
|Actual Study Completion Date :||October 5, 2010|
Experimental: Maca Root
Subjects in this arm will be given 3g/day of maca root for 12 weeks
Drug: Maca Root
3g/day of Maca Root for 12 weeks.
Other Name: Lepidium
Placebo Comparator: Placebo
Subjects in this arm will receive inactive placebo for 12 weeks.
Placebo provided by research pharmacy daily for 12 weeks.
Other Name: Inactive placebo
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568126
|United States, Massachusetts|
|Depression Clinical and Research Program, Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Christina Dording, MD||Massachusetts General Hospital|
|Study Director:||David Mischoulon, MD, PhD||Massachusetts General Hospital|