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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00831415
First received: January 27, 2009
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: desvenlafaxine succinate sustained release tablets
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score [ Time Frame: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Day 308 or FOT Evaluation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Extension Study) up to Day 308 or FOT Evaluation ] [ Designated as safety issue: No ]
    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.


Enrollment: 304
Study Start Date: March 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
DVS SR
Drug: desvenlafaxine succinate sustained release tablets
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.
Other Name: DVS-233; Pristiq

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00831415

Locations
Japan
Pfizer Investigational Site
Aichi, Japan
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Fukushima, Japan
Pfizer Investigational Site
Gunma, Japan
Pfizer Investigational Site
Hiroshima, Japan
Pfizer Investigational Site
Hokkaido, Japan
Pfizer Investigational Site
Hyogo, Japan
Pfizer Investigational Site
Ishikawa, Japan
Pfizer Investigational Site
Kanagawa, Japan
Pfizer Investigational Site
Kumamoto, Japan
Pfizer Investigational Site
Kyoto, Japan
Pfizer Investigational Site
Osaka, Japan
Pfizer Investigational Site
Saga, Japan
Pfizer Investigational Site
Saitama, Japan
Pfizer Investigational Site
Shiga, Japan
Pfizer Investigational Site
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00831415     History of Changes
Other Study ID Numbers: 3151A1-3350, B2061002
Study First Received: January 27, 2009
Results First Received: December 22, 2011
Last Updated: December 22, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
United States: Institutional Review Board

Keywords provided by Pfizer:
Open-label Long-term extension study

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
O-desmethylvenlafaxine
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014