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Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
desvenlafaxine succinate sustained release tablets
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Open-label Long-term extension study

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (MDD), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.

Exclusion Criteria:

  • Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

DVS SR

Outcomes

Primary Outcome Measures

Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score
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. Higher scores indicate greater severity. FOT evaluation is defined as the last "on-therapy" evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.

Secondary Outcome Measures

Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)
CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score
CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.

Full Information

First Posted
January 27, 2009
Last Updated
November 15, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00831415
Brief Title
Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)
Official Title
A 10-Month Open-Label Evaluation Of The Long-Term Safety Of Desvenlafaxine Succinate Sustained Release In Japanese Adults With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depressive disorder (MDD). The secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Open-label Long-term extension study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
DVS SR
Intervention Type
Drug
Intervention Name(s)
desvenlafaxine succinate sustained release tablets
Other Intervention Name(s)
DVS-233; Pristiq
Intervention Description
25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.
Primary Outcome Measure Information:
Title
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score
Description
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. Higher scores indicate greater severity. FOT evaluation is defined as the last "on-therapy" evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit.
Time Frame
Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation
Title
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.
Time Frame
Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment
Secondary Outcome Measure Information:
Title
Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)
Description
CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame
Day 308 or FOT Evaluation
Title
Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score
Description
CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.
Time Frame
Baseline (Extension Study) up to Day 308 or FOT Evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (MDD), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study. Exclusion Criteria: Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukushima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Gunma
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hiroshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ishikawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kumamoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saga
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shiga
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3350
Description
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Study Evaluating Long-Term Safety of Desvenlafaxine Succinate Sustained Release With Japanese Adult Subjects in Major Depressive Disorder (MDD)

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