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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831415
• Other study ID #: 3151A1-3350
• Secondary ID: B2061002
• Status: Completed
• Phase: Phase 3
• Start date: March 2009
• Est. completion date: March 2011

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation
Primary	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.	Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment
Secondary	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.	Day 308 or FOT Evaluation
Secondary	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.	Baseline (Extension Study) up to Day 308 or FOT Evaluation

External Links

•   To obtain contact information for a study center near you, click here.