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Sponsors and Collaborators: |
Massachusetts General Hospital National Alliance for Research on Schizophrenia and Depression |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00575328 |
The purpose of this research study is to find out whether Maca Root is effective for treating sexual dysfunction in females that is caused by the treatment for bipolar disorder. 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. We suspect that Maca Root will result in a significant reduction in sexual dysfunction when compared to a placebo group.
Condition | Intervention | Phase |
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Sexual Dysfunction Bipolar Disorder |
Drug: Maca Root Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | A Double-Blind, Placebo Controlled Study of Maca Root for the Treatment of Sexual Dysfunction Associated With the Treatment Regimen for Bipolar Disorder in Females |
Estimated Enrollment: | 80 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 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:
Exclusion Criteria:
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, MGH ( Christina Dording, MD ) |
Study ID Numbers: | 2007-P-001471 |
Study First Received: | December 14, 2007 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00575328 |
Health Authority: | United States: Food and Drug Administration |
Sexual Dysfunction Bipolar Disorder |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder Mood Disorders Psychotic Disorders |
Pathologic Processes Disease |