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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00831415
First received: January 27, 2009
Last updated: December 22, 2011
Last verified: December 2011
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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
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 October 18, 2012
