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NCT00181961 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction
A Phase 3 study of Depression and Sexual Dysfunction, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00181961: Completed Phase 3 study of Depression and Sexual Dysfunction, sponsored by Massachusetts General Hospital.
NCT00181961 is a Phase 3 study of Depression and Sexual Dysfunction that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00181961, a Phase 3 study of Depression and Sexual Dysfunction, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Full title: Massachusetts General Hospital Sexual Dysfunction Inventory Minimum score for Men: 5 Minimum score for Women: 4 Maximum score for Men: 30 Maximum score for Women: 24 \*One item on the measure is for men only A score of a 5 (4 for women) indicates improvement in sexual function. A score of 10 (8 for women) indicates no change. A score higher than 10 (8 for women) indicates a level of sexual dysfunction.
Conditions Studied
Interventions
- DRUG Maca Root
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
What the finished NCT00181961 record still lists
NCT00181961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Maca Root is the first listed.
NCT00181961 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00181961 about?
NCT00181961 is a clinical study titled "Safety and Effectiveness Study of Maca Root to Treat Antidepressant-Induced Sexual Dysfunction". 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....
What is the current status of trial NCT00181961?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2007-12. Estimated completion is 2010-06.
What conditions does trial NCT00181961 study?
This clinical trial studies the following conditions: Depression, Sexual Dysfunction.
What interventions are being tested in trial NCT00181961?
The interventions under investigation include: Maca Root (DRUG).
Who is sponsoring clinical trial NCT00181961?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00181961 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00181961's enrollment target sits among peer trials
20 612th of 679 higher than 58 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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