Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder

ClinicalTrials.gov ID: NCT00887224

Public ClinicalTrials.gov record NCT00887224. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study To Evaluate The Efficacy And Safety Of 50 mg/Day Of DVS SR In Adult Outpatients With Major Depressive Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial.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 Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period.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.

Study identification

NCT ID: NCT00887224
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Pfizer; Industry
Enrollment: 874 participants

Conditions and interventions

Conditions

Major Depressive Disorder

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 31, 2009
Primary completion: Feb 28, 2011
Completion: Feb 28, 2011
Last update posted: Nov 20, 2014

2009 – 2011

United States locations

U.S. sites: 21
U.S. states: 11
U.S. cities: 19

Facility	City	State	ZIP	Site status
Pfizer Investigational Site	Beverly Hills	California	90210	—
Pfizer Investigational Site	Encino	California	91316	—
Pfizer Investigational Site	Los Alamitos	California	90720	—
Pfizer Investigational Site	Orange	California	92868	—
Pfizer Investigational Site	Upland	California	91786	—
Pfizer Investigational Site	Aurora	Colorado	80045	—
Pfizer Investigational Site	Jacksonville	Florida	32256	—
Pfizer Investigational Site	South Miami	Florida	33143	—
Pfizer Investigational Site	St. Petersburg	Florida	33702	—
Pfizer Investigational Site	St. Petersburg	Florida	33716	—
Pfizer Investigational Site	Atlanta	Georgia	30328	—
Pfizer Investigational Site	Smyrna	Georgia	30080	—
Pfizer Investigational Site	Hoffman Estates	Illinois	60169	—
Pfizer Investigational Site	Rockville	Maryland	20852	—
Pfizer Investigational Site	New York	New York	10024	—
Pfizer Investigational Site	New York	New York	10128	—
Pfizer Investigational Site	Rochester	New York	14618	—
Pfizer Investigational Site	Dayton	Ohio	45408	—
Pfizer Investigational Site	Portland	Oregon	97210	—
Pfizer Investigational Site	San Antonio	Texas	78247	—
Pfizer Investigational Site	Seattle	Washington	98104	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 69 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00887224, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 20, 2014 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00887224 live on ClinicalTrials.gov.

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