| Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD |
| 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 |
| This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder. |
| 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. |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Depressive Disorder, Major |
- Drug: DVS SR
Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper
- Drug: Paroxetine
20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper
|
- Experimental: A
DVS SR 50mg/day
Intervention: Drug: DVS SR
- Experimental: B
DVS SR 100mg/day
Intervention: Drug: DVS SR
- Experimental: C
DVS SR 200mg/day
Intervention: Drug: DVS SR
- Active Comparator: D
Paroxetine 20mg/day
Intervention: Drug: Paroxetine
|
| Not Provided |
| |
| Completed |
| 807 |
| February 2009 |
| February 2009 (Final data collection date for primary outcome measure) |
|
Primary Inclusion Criteria:
- Outpatient men and women at least 18 years of age.
- 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.
- Have a HAM D17 total score ?20 at the screening and baseline (study day 1) visit.
Primary Exclusion Criteria:
- Treatment with DVS SR at any time in the past.
- 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.
- 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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| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| China, India, Korea, Republic of, Taiwan |
| |
| |
| NCT00445679 |
| 3151A1-336 |
| Not Provided |
| Not Provided |
| Not Provided |
| Wyeth is now a wholly owned subsidiary of Pfizer |
| Wyeth is now a wholly owned subsidiary of Pfizer |
| Not Provided |
| Study Director: |
Medical Monitor |
Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: |
Trial Manager |
For China: [email protected]
|
|
| Wyeth is now a wholly owned subsidiary of Pfizer |
| October 2013 |
