Clinical trial NCT00831415: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Open-label Long-term extension study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-29
Enrollment: 304
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score
timeFrame: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation
measure: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment
Secondary outcomes:
measure: Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)
timeFrame: Day 308 or FOT Evaluation
measure: Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score
timeFrame: Baseline (Extension Study) up to Day 308 or FOT Evaluation
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Pfizer Investigational Site
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Fukushima
country: Japan
facility: Pfizer Investigational Site
city: Gunma
country: Japan
facility: Pfizer Investigational Site
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Hokkaido
country: Japan
facility: Pfizer Investigational Site
city: Hyogo
country: Japan
facility: Pfizer Investigational Site
city: Ishikawa
country: Japan
facility: Pfizer Investigational Site
city: Kanagawa
country: Japan
facility: Pfizer Investigational Site
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Saga
country: Japan
facility: Pfizer Investigational Site
city: Saitama
country: Japan
facility: Pfizer Investigational Site
city: Shiga
country: Japan
facility: Pfizer Investigational Site
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: