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Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Beijing, , 100083 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00445679
Pfizer
Completed
Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD

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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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
807
February 2009
February 2009   (Final data collection date for primary outcome measure)

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.
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

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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