Venlafaxine ER long-term extension study for major depressive disorder
Phase 3
- Conditions
- Major depressive disorder
- Registration Number
- JPRN-jRCT2080221669
- Lead Sponsor
- Pfizer Japan Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability<br>Month 10
- Secondary Outcome Measures
Name Time Method -Hamilton Rating Scale for Depression, 17 items (HAM-D17) total score<br>-Clinical Global Impression-Severity (CGI-S)<br>-Quick Inventory of Depressive Symptomatology-Self Report, 16 items (QIDS16-SR-J) total score<br>-Clinical Global Impression-Improvement (CGI-I)<br>Month 10