Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00445679 |
Recruitment Status :
Completed
First Posted : March 9, 2007
Results First Posted : November 3, 2013
Last Update Posted : November 3, 2013
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Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Depressive Disorder, Major |
Interventions |
Drug: DVS SR Drug: Paroxetine |
Enrollment | 807 |
Participant Flow
Recruitment Details | Subjects were recruited in China, India, South Korea and Taiwan from July 2007 to December 2008. |
Pre-assignment Details | After a 4 to 21 day screening period, eligible subjects were treated for up to 8 weeks. |
Arm/Group Title | DVS SR 50 | DVS SR 100 | DVS SR 200 | Paroxetine 20 |
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Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day | Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day | Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day | Paroxetine 20 mg/day |
Period Title: Overall Study | ||||
Started | 203 | 203 | 205 | 196 |
Completed | 155 | 157 | 139 | 149 |
Not Completed | 48 | 46 | 66 | 47 |
Reason Not Completed | ||||
Adverse Event | 22 | 12 | 30 | 19 |
Failed to return | 1 | 3 | 2 | 2 |
Physician Decision | 0 | 0 | 1 | 0 |
Lost to Follow-up | 10 | 6 | 6 | 5 |
Compliance | 3 | 2 | 1 | 2 |
Withdrawal of Informed Consent | 0 | 0 | 1 | 0 |
Protocol Violation | 2 | 3 | 3 | 1 |
Withdrawal by Subject | 8 | 14 | 20 | 18 |
Lack of Efficacy | 2 | 6 | 2 | 0 |
Baseline Characteristics
Arm/Group Title | DVS SR 50 | DVS SR 100 | DVS SR 200 | Paroxetine 20 | Total | |
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Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day | Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day | Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day | Paroxetine 20 mg/day | Total of all reporting groups | |
Overall Number of Baseline Participants | 203 | 203 | 205 | 196 | 807 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 203 participants | 203 participants | 205 participants | 196 participants | 807 participants | |
38.63 (12.96) | 39.26 (13.22) | 39.26 (14.69) | 38.27 (13.22) | 38.86 (13.53) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 203 participants | 203 participants | 205 participants | 196 participants | 807 participants | |
Female |
125 61.6%
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129 63.5%
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118 57.6%
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117 59.7%
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489 60.6%
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Male |
78 38.4%
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74 36.5%
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87 42.4%
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79 40.3%
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318 39.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: | U. S. Contact Center |
Organization: | Wyeth |
EMail: | clintrialresults@wyeth.com |
Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00445679 |
Other Study ID Numbers: |
3151A1-336 |
First Submitted: | March 6, 2007 |
First Posted: | March 9, 2007 |
Results First Submitted: | February 26, 2010 |
Results First Posted: | November 3, 2013 |
Last Update Posted: | November 3, 2013 |