NCT00445679

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
807

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2007

Geographic Reach
4 countries

43 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

November 4, 2013

Completed
Last Updated

November 4, 2013

Status Verified

October 1, 2013

Enrollment Period

1.6 years

First QC Date

March 6, 2007

Results QC Date

February 26, 2010

Last Update Submit

October 8, 2013

Conditions

Depressive Disorder, Major

Keywords

major depressive disorderMDDdepression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Clinical Global Impressions Scale-Improvement (CGI-I) Scores

    8 weeks

  • Clinical Global Impressions Scale-Severity of Illness (CGI-S) Scores

    8 weeks

  • Montgomery and Asberg Depression Rating Scale (MADRS) Total Score Mean Change From Baseline

    Baseline and 8 weeks

  • Visual Analog Scale-pain Intensity (VAS-PI) Score Mean Change From Baseline

    8 weeks

  • Hamilton Rating Scale for Depression, 6-item (HAM-D6) Score Mean Change From Baseline

    8 weeks

  • +1 more secondary outcomes

Study Arms (4)

A

EXPERIMENTAL

DVS SR 50mg/day

Drug: DVS SR

B

EXPERIMENTAL

DVS SR 100mg/day

Drug: DVS SR

C

EXPERIMENTAL

DVS SR 200mg/day

Drug: DVS SR

D

ACTIVE COMPARATOR

Paroxetine 20mg/day

Drug: Paroxetine

Interventions

DVS SRDRUG

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

ABC
ParoxetineDRUG

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

D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (43)

Unknown Facility

Beijing, 100083, China

Location

Unknown Facility

Beijing, 100088, China

Location

Unknown Facility

Guangdong Province, 510370, China

Location

Unknown Facility

Hunan Province, 410011, China

Location

Unknown Facility

Jiangsu Province, 210029, China

Location

Unknown Facility

Shanghai, 200030, China

Location

Unknown Facility

Shanghai, 200065, China

Location

Unknown Facility

Shanxi Province, 710032, China

Location

Unknown Facility

Sichuan Province, 610041, China

Location

Unknown Facility

Yunnan Province, 650032, China

Location

Unknown Facility

Zhejiang Province, 310003, China

Location

Unknown Facility

Andhra Pradesh, 500 038, India

Location

Unknown Facility

Andhra Pradesh, 500034, India

Location

Unknown Facility

Andhra Pradesh, 517 507, India

Location

Unknown Facility

Andhra Pradesh, 530 002, India

Location

Unknown Facility

Chandigarh, 160012, India

Location

Unknown Facility

Gujarat, 380006, India

Location

Unknown Facility

Gujarat, 380013, India

Location

Unknown Facility

Karnataka, 575 001, India

Location

Unknown Facility

Karnataka, 575018, India

Location

Unknown Facility

Maharashtra, 400 012, India

Location

Unknown Facility

Maharashtra, 400 026, India

Location

Unknown Facility

Maharashtra, 411001, India

Location

Unknown Facility

Mumbai Maharashtra, H19400 022, India

Location

Unknown Facility

New Delhi, 110002, India

Location

Unknown Facility

Punjab, 141001, India

Location

Unknown Facility

Uttar Pradesh, 226003, India

Location

Unknown Facility

Incheon, 400-711, South Korea

Location

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 135-710, South Korea

Location

Unknown Facility

Seoul, 135-720, South Korea

Location

Unknown Facility

Seoul, 137-701, South Korea

Location

Unknown Facility

Seoul, 138-736, South Korea

Location

Unknown Facility

Seoul, 140-757, South Korea

Location

Unknown Facility

Seoul, 150-719, South Korea

Location

Unknown Facility

Seoul, 158-710, South Korea

Location

Unknown Facility

Chang-hua, ROC 500, Taiwan

Location

Unknown Facility

Kaohsiung City, ROC 80708, Taiwan

Location

Unknown Facility

Taipei, ROC 100, Taiwan

Location

Unknown Facility

Taipei, ROC 111, Taiwan

Location

Unknown Facility

Taipei, ROC 112, Taiwan

Location

Unknown Facility

Taipei, ROC 114, Taiwan

Location

Unknown Facility

Taipei, ROC 220, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
U. S. Contact Center
Organization
Wyeth
clintrialresults@wyeth.com

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For China: medinfo@wyeth.com

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 9, 2007

Study Start

July 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

November 4, 2013

Results First Posted

November 4, 2013

Record last verified: 2013-10

Locations

TW(7)CN(11)IN(16)KR(9)