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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: DVS SR; Drug: Paroxetine

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.

• Study Type: Interventional
• Enrollment (Actual): 807
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100083
  • Beijing, China, 100088
  • Guangdong Province, China, 510370
  • Hunan Province, China, 410011
  • Jiangsu Province, China, 210029
  • Shanghai, China, 200030
  • Shanghai, China, 200065
  • Shanxi Province, China, 710032
  • Sichuan Province, China, 610041
  • Yunnan Province, China, 650032
  • Zhejiang Province, China, 310003
• India
  • Andhra Pradesh, India, 500 038
  • Andhra Pradesh, India, 500034
  • Andhra Pradesh, India, 517 507
  • Andhra Pradesh, India, 530 002
  • Chandigarh, India, 160012
  • Gujarat, India, 380006
  • Gujarat, India, 380013
  • Karnataka, India, 575 001
  • Karnataka, India, 575018
  • Maharashtra, India, 400 012
  • Maharashtra, India, 400 026
  • Maharashtra, India, 411001
  • Mumbai Maharashtra, India, H19400 022
  • New Delhi, India, 110002
  • Punjab, India, 141001
  • Uttar Pradesh, India, 226003
• Korea, Republic of
  • Incheon, Korea, Republic of, 400-711
  • Seoul, Korea, Republic of, 137-701
  • Seoul, Korea, Republic of, 158-710
  • Seoul, Korea, Republic of, 138-736
  • Seoul, Korea, Republic of, 110-744
  • Seoul, Korea, Republic of, 135-710
  • Seoul, Korea, Republic of, 135-720
  • Seoul, Korea, Republic of, 140-757
  • Seoul, Korea, Republic of, 150-719
• Taiwan
  • Chang-Hua, Taiwan, ROC 500
  • KaoHsiung, Taiwan, ROC 80708
  • Taipei, Taiwan, ROC 100
  • Taipei, Taiwan, ROC 111
  • Taipei, Taiwan, ROC 112
  • Taipei, Taiwan, ROC 114
  • Taipei, Taiwan, ROC 220

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; DVS SR 50mg/day	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
Experimental: B; DVS SR 100mg/day	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
Experimental: C; DVS SR 200mg/day	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
Active Comparator: D; Paroxetine 20mg/day	Drug: Paroxetine; 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17)	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impressions Scale-Improvement (CGI-I) Scores	CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the subject's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse).	8 weeks
Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores	CGI-S is a global rating scale that measures the severity of a subject's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with subjects who have the same diagnosis (1= normal, not at all ill; 7= among the most extremely ill).	8 weeks
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline	Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).	Baseline and 8 weeks
Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline	The VAS-PI is a self-rated visual analog scale for the assessment of pain. Scores on the VAS-PI range from 0 (no pain) to 10 (worst possible pain). A decrease in VAS-PI overall scores indicates a subject's assessment of an improvement in pain.	8 weeks
Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline	HAM-D6: standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression.	8 weeks
Covi Anxiety Scale Score Mean Change From Baseline	Covi anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, 5 = Very much. Total score ranges from 3 to 15; higher score indicates more anxiety.	8 weeks

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Trial Manager, For China: medinfo@wyeth.com

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: March 6, 2007
• First Submitted That Met QC Criteria: March 8, 2007
• First Posted (Estimate): March 9, 2007

Study Record Updates

• Last Update Posted (Estimate): November 3, 2013
• Last Update Submitted That Met QC Criteria: October 8, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: depression; MDD; major depressive disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: 3151A1-336

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No