Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181961
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2005-09-13
Brief Title:
Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Dose-Finding Study of the Tolerability and Efficacy of Maca Root in Patients With Antidepressant-Induced Sexual Dysfunction
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the dose of Maca Root effective for the treatment of antidepressant-induced sexual dysfunction in patients with DSM-IV defined Major Depressive Disorder We propose to carry out a dose-finding pilot study to determine the minimum effective dose of Maca Root We hypothesize that patients who receive Maca Root will experience alleviation of their sexual dysfunction and this effect will be more pronounced in those who receive higher doses of maca root
Detailed Description:
The purpose of this study is to determine whether Maca Root is effective for the treatment of antidepressant-induced sexual dysfunction and to further determine whether higher doses of Maca Root powder would be more effective than lower doses in reducing the symptoms of antidepressant-induced sexual dysfunction An additional aim of the study is to document the safety and tolerability of Maca Root which could be particularly helpful in treating antidepressant-induced sexual dysfunction in elderly and cardiac-impaired populations taking oral nitrates who may not be eligible for treatment with the current oral phosphodiesterase inhibitors
Subjects will be randomized into two arms of 10 for this 12-week study The study will be double blind with regard to doses received Ten subjects will receive 1500mgday of maca for the 12-week period and the other 10 subjects will receive 3000mgday of maca per day for the 12-week study period Patients will be seen every other week There is no placebo arm
At the final study visit week 12 subjects will be evaluated to see if their sexual function has returned
After careful review of the literature we have found that there are very few studies that have evaluated Maca Root in humans However the one very relevant study completed by Gonzalez and colleagues looked at doses of 1500 and 3000mg in men and found there were increased sexual interests on both doses Thus since this is a dose-finding study we believe this dose is an appropriate place to begin
Hypotheses A
The response rate will be higher for the high-dose maca group compared to the low-dose group and this response will be comparable to the 50-85 reported with sildenafil
Hypothesis B
There will be a statistically significant difference in the magnitude of response between the two testing conditions as measured by a decrease in baseline sexual dysfunction scores The reduction in sexual dysfunction scores will be greater in the high-dose maca group than in the low-dose maca group
Subjects will be randomized into two arms of 10 for this 12-week study The study will be double blind with regard to doses received Ten subjects will receive 1500mgday of maca for the 12-week period and the other 10 subjects will receive 3000mgday of maca per day for the 12-week study period Patients will be seen every other week There is no placebo arm
At the final study visit week 12 subjects will be evaluated to see if their sexual function has returned
After careful review of the literature we have found that there are very few studies that have evaluated Maca Root in humans However the one very relevant study completed by Gonzalez and colleagues looked at doses of 1500 and 3000mg in men and found there were increased sexual interests on both doses Thus since this is a dose-finding study we believe this dose is an appropriate place to begin
Hypotheses A
The response rate will be higher for the high-dose maca group compared to the low-dose group and this response will be comparable to the 50-85 reported with sildenafil
Hypothesis B
There will be a statistically significant difference in the magnitude of response between the two testing conditions as measured by a decrease in baseline sexual dysfunction scores The reduction in sexual dysfunction scores will be greater in the high-dose maca group than in the low-dose maca group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None