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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00445679 |
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Date of registration:
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06/03/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD
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Scientific title:
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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 |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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807 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00445679 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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China
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India
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Korea, Republic of
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Taiwan
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For China: medinfo@wyeth.com |
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Key inclusion & exclusion criteria
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Primary Inclusion Criteria:
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 Exclusion Criteria:
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Depressive Disorder, Major
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Intervention(s)
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Drug: Paroxetine
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Drug: DVS SR
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Primary Outcome(s)
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Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline
[Time Frame: Baseline and 8 weeks]
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Covi Anxiety Scale Score Mean Change From Baseline
[Time Frame: 8 weeks]
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Clinical Global Impressions Scale-Improvement (CGI-I) Scores
[Time Frame: 8 weeks]
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Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores
[Time Frame: 8 weeks]
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Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline
[Time Frame: 8 weeks]
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Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline
[Time Frame: 8 weeks]
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Secondary ID(s)
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3151A1-336
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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