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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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ClinicalTrials.gov Identifier: NCT00831415
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : January 30, 2012
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: desvenlafaxine succinate sustained release tablets Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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 :
  1. Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Day 308 or FOT Evaluation ]
    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.

  2. 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 ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00831415     History of Changes
Other Study ID Numbers: 3151A1-3350
B2061002
First Posted: January 29, 2009    Key Record Dates
Results First Posted: January 30, 2012
Last Update Posted: December 7, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
Depressive Disorder, Major
Disease
Depressive Disorder
Depression
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs