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

NCT ID: NCT00445679

Last Updated: 2013-11-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

807 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-02-28

Brief Summary

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This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.

Detailed Description

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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.

Conditions

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Depressive Disorder, Major

Keywords

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major depressive disorder MDD depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

DVS SR 50mg/day

Group Type EXPERIMENTAL

DVS SR

Intervention Type DRUG

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

B

DVS SR 100mg/day

Group Type EXPERIMENTAL

DVS SR

Intervention Type DRUG

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

C

DVS SR 200mg/day

Group Type EXPERIMENTAL

DVS SR

Intervention Type DRUG

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

D

Paroxetine 20mg/day

Group Type ACTIVE_COMPARATOR

Paroxetine

Intervention Type DRUG

20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper

Interventions

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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

Intervention Type DRUG

Paroxetine

20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For China: [email protected]

Locations

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Beijing, , China

Site Status

Beijing, , China

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Guangdong Province, , China

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Hunan Province, , China

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Jiangsu Province, , China

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Shanghai, , China

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Shanghai, , China

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Shanxi Province, , China

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Sichuan Province, , China

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Yunnan Province, , China

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Zhejiang Province, , China

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Andhra Pradesh, , India

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Andhra Pradesh, , India

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Andhra Pradesh, , India

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Andhra Pradesh, , India

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Chandigarh, , India

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Gujarat, , India

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Gujarat, , India

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Karnataka, , India

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Karnataka, , India

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Maharashtra, , India

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Maharashtra, , India

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Maharashtra, , India

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Mumbai Maharashtra, , India

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New Delhi, , India

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Punjab, , India

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Uttar Pradesh, , India

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Incheon, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Chang-hua, , Taiwan

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Kaohsiung City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Countries

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China India South Korea Taiwan

Other Identifiers

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3151A1-336

Identifier Type: -

Identifier Source: org_study_id