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NCT00304746 · ClinicalTrials.gov registry record · Phase 4
AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
A Phase 4 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT00304746: Completed Phase 4 study, sponsored by Mclean Hospital.
NCT00304746 is a Phase 4 study that has completed, run by Mclean Hospital. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00304746, a Phase 4 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study Summary
We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant. During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatment-refractory depression and low or borderline low testosterone levels will be treated with either AndroGel or placebo. Following this nine week, double-blind phase, eligible subjects will have the option to continue into a six month, open-label phase during which time all subjects will receive the AndroGel patch.
Primary Outcome
The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).
Interventions
- DRUG Placebo
- DRUG Testosterone gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2006-04 |
| Est. Completion | 2009-04 |
| Phase | Phase 4 |
What the finished NCT00304746 record still lists
NCT00304746 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00304746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00304746 about?
NCT00304746 is a clinical study titled "AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment". We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant. During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65...
What is the current status of trial NCT00304746?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2006-04. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00304746?
The interventions under investigation include: Placebo (DRUG), Testosterone gel (DRUG).
Who is sponsoring clinical trial NCT00304746?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00304746's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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