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NCT00887224 · ClinicalTrials.gov registry record · Phase 3
Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 874
- Enrollment target
NCT00887224 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 874 participants.
The verdict
NCT00887224, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 874 participants
- Enrollment target
Study Summary
The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned. The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.
Interventions
- DRUG Placebo
- DRUG Desvenlafaxine succinate sustained release 50 mg
- DRUG Desvenlafaxine succinate sustained release 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 874 participants |
| Start Date | 2009-06 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00887224
The ClinicalTrials.gov registry entry for NCT00887224 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 874 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00887224 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00887224 about?
NCT00887224 is a clinical study titled "Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder". The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sus...
What is the current status of trial NCT00887224?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 874 participants. The study started on 2009-06. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00887224?
The interventions under investigation include: Placebo (DRUG), Desvenlafaxine succinate sustained release 50 mg (DRUG), Desvenlafaxine succinate sustained release 25 mg (DRUG).
Who is sponsoring clinical trial NCT00887224?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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