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Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Nippon Medical School Chiba Hokusoh Hospital
Inzai, Chiba, 270-1694 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Outpatients who have completed 8 weeks double-blind study (B2411263), without major
protocol violations or tolerability concerns in the opinion of the investigator.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Clinically important abnormalities on baseline (Week 8 of the double-blind study)
physical examination, or any unresolved clinically significant abnormalities on
electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week
8 in the previous double-blind study.

- Significant risk of suicide based on clinical judgment.

- Use of prohibited treatments

NCT01485887
Pfizer
Completed
Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)

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Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)
A Open-label Long-term Extension Study To Evaluate The Safety And Efficacy Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder
This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Venlafaxine ER
Treatment phase: 10 months (75-225 mg/day), oral administration Tapering phase: 1-3 weeks (stepwise dose reduction: 150-37.5 mg/day), oral administration
Experimental: Venlafaxine ER
Intervention: Drug: Venlafaxine ER
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2014
January 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Outpatients who have completed 8 weeks double-blind study (B2411263), without major protocol violations or tolerability concerns in the opinion of the investigator.

Exclusion Criteria:

  • Clinically important abnormalities on baseline (Week 8 of the double-blind study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week 8 in the previous double-blind study.
  • Significant risk of suicide based on clinical judgment.
  • Use of prohibited treatments
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01485887
B2411264
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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