Study Evaluating DVS-233 SR In Adult Outpatients With Maj... | NCT00073762

Studies
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

NCT00073762

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Aug 19, 2009Estimated

Enrollment

375Actual

Phase

Phase 3

Conditions

Major Depressive Disorder

Interventions

DVS-233 SR

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Sep 2004Actual

Completion Date

Sep 2004Actual

First Submitted Date

Dec 4, 2003

First Submission Date that Met QC Criteria

Dec 7, 2003

First Posted Date

Dec 8, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2009

Last Update Posted Date

Aug 19, 2009Estimated

Description Module

Brief Summary

Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] less than or equal to 7) versus those subjects receiving placebo.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

375Actual

Name	Type	Description	Arm Group Labels	Other Names
DVS-233 SR	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients
Sexually active women participating in the study must use a medically acceptable form of contraception
Subjects must have a primary diagnosis of major depressive disorder of 4 on Clinical Global Impressions-Severity scale (CGI-S)

Exclusion Criteria:

Treatment with DVS-233 SR at any time in the past
Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1
Known hypersensitivity to venlafaxine (IR or ER)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor, MD	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25758058	Derived	Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders