Phase 3
Completed N=50
Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)
Source: ClinicalTrials.gov NCT01485887 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
May 2015
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 49; 2 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
49; 2 | — |
| PRIMARY Number of Participants With Clinical Significant Vital Changes |
3; 4; 1 | — |
| PRIMARY Number of Participants With Clinical Significant Laboratory Tests Changes |
1; 2; 3; 1; 1; 4 | — |
| PRIMARY Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes |
5; 0; 0; 17; 4; 1 | — |
| PRIMARY Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories |
0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point |
-1.0; -1.5; -2.2; -2.9; -3.4; -3.9 | — |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point |
-0.1; -0.3; -0.3; -0.4; -0.6; -0.6 | — |
| SECONDARY Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point |
3.8; 3.5; 3.3; 3.1; 2.9; 2.9 | — |
| SECONDARY Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point |
-2.7; -3.8; -4.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01485887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.