|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
National Alliance for Research on Schizophrenia and Depression |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00575328 |
Purpose
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 |
|---|---|---|
|
Sexual Dysfunction Bipolar Disorder |
Drug: Maca Root Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1. Maca Root
Subjects in this arm will be given 3g/day of Maca Root.
|
Drug: Maca Root
3g/day of Maca Root for 12 weeks
|
|
Placebo Comparator: 2. Control
Subjects in this arm will receive placebo.
|
Drug: Placebo
Placebo provided by research pharmacy daily for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Depression Clinical and Research Program, Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Christina Dording, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Christina Dording, MD, Massachusetts General Hospital, Depression Clinical and Research Program |
| ClinicalTrials.gov Identifier: | NCT00575328 History of Changes |
| Other Study ID Numbers: | 2007-P-001471 |
| Study First Received: | December 14, 2007 |
| Last Updated: | June 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Sexual Dysfunction Bipolar Disorder |
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders |