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Sponsors and Collaborators: |
Massachusetts General Hospital National Institutes of Health (NIH) |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00568126 |
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.
Condition | Intervention | Phase |
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Antidepressant Induced Sexual Dysfunction |
Drug: Maca Root Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Double-Blind, Placebo Controlled Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females |
Estimated Enrollment: | 80 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | October 2009 |
Arms | Assigned Interventions |
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1. Maca Root: Experimental
Subjects in this arm will be given 3g/day of maca root
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Drug: Maca Root
3g/day of Maca Root for 12 weeks.
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2. Control: Placebo Comparator
Subjects in this arm will receive placebo.
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Drug: Placebo
Placebo provided by research pharmacy daily for 12 weeks
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject must have been consistently experiencing at least one of the following criteria for at least 4 weeks, with distress or disability:
Exclusion Criteria:
systematic experience with drug-supplement interactions (i.e. - cyclosporine, digoxin, warfarin, and antiretrovirals)
Contact: Sarah E Chuzi, BA | 617-724-3520 | SCHUZI@PARTNERS.ORG |
United States, Massachusetts | |
Depression Clinical and Research Program, Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Christina Dording, MD |
Principal Investigator: | Christina Dording, MD | Massachusetts General Hospital |
Responsible Party: | Depression Clinical and Research Program, Massachusetts General Hospital ( Christina Dording, MD ) |
Study ID Numbers: | 2007P001090, NIH 1R21AT004385-01, FDA R21 AT004385-01 |
Study First Received: | December 3, 2007 |
Last Updated: | December 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00568126 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Antidepressant Induced Sexual Dysfunction Depression Sexual Dysfunction |
Depression Psychotropic Drugs Depressive Disorder Antidepressive Agents |
Therapeutic Uses Psychotropic Drugs Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |