Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
NCT00445679
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Adult Trials: 18+ Years
1. Outpatient men and women at least 18 years of age.
2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features.
3. Have a HAM D17 total score ≥20 at the screening and baseline (study day 1) visit.
Primary
1. Treatment with DVS SR at any time in the past.
2. Significant risk of suicide based on clinical judgment, including common suicidal
thoughts and suicide having been considered as a possible solution even without
specific plans or intent.
3. Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled
hypertension), ophthalmologic, neurologic, or any other medical condition that might
confound the study or put the subject at greater risk during study participation.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD | ||||||
| Official Title ICMJE | A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder | ||||||
| Brief Summary | This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder. | ||||||
| Detailed Description | The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Depressive Disorder, Major | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 807 | ||||||
| Original Enrollment ICMJE | 915 | ||||||
| Actual Study Completion Date ICMJE | February 2009 | ||||||
| Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | China, India, Korea, Republic of, Taiwan | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00445679 | ||||||
| Other Study ID Numbers ICMJE | 3151A1-336 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Verification Date | October 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||