Paroxetine-Referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD - Full Text View

Purpose

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

Condition	Intervention	Phase
Depressive Disorder, Major	Drug: DVS-233 SR Drug: Paroxetine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Paroxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Sustained-Release Tables in Adult Outpatients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

The primary efficacy outome measure will be the mean total score of the 17-item Hamilton Depression Scale (HAM-D17). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impressions Scale Severity of Illness (CGI-S), the Clinical Global Impressions Scale Improvement (CGI-I), the Montgomery and Asberg Depression Rating Scale total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The Hamilton Depression rating scale - 6 item (HAM-D6), Covi-Anxiety Scale, and the visual analog scale-pain intensity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	800
Study Start Date:	May 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: DVS-233 SR Arm 1: 50mg DVS tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS tablet, QD, 8 weeks treatment with 2 week taper
Experimental: B	Drug: DVS-233 SR Arm 1: 50mg DVS tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS tablet, QD, 8 weeks treatment with 2 week taper
Experimental: C	Drug: DVS-233 SR Arm 1: 50mg DVS tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS tablet, QD, 8 weeks treatment with 2 week taper
Active Comparator: D	Drug: Paroxetine 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445679

Show 43 Study Locations

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For China: medinfo@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00445679 History of Changes
Other Study ID Numbers:	3151A1-336
Study First Received:	March 6, 2007
Last Updated:	July 8, 2009
Health Authority:	China: Ministry of Health India: Ministry of Health Korea: Food and Drug Administration Taiwan: Department of Health United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

major depressive disorder
MDD
depression

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013