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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 is a Phase 4 study that has completed, run by Mclean Hospital. The registered enrollment target is 100 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Testosterone gel

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2006-04
Est. Completion 2009-04
Phase Phase 4

Sponsor

Mclean Hospital

140 total trials

What the Registry Record Tells You About NCT00304746

The ClinicalTrials.gov registry entry for NCT00304746 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00304746 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.