Phase 3
Completed N=535
Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Source: ClinicalTrials.gov NCT00694304 ↗Enrolled (actual)
535
Serious AEs
3.4%
Results posted
Apr 2014
Primary outcomePrimary: Number of Patients With Adverse Events (AEs) — 391; 18; 42 participants
Summary
The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) |
391; 18; 42 | — |
| PRIMARY Percentage of Patients Who Withdrew Due to Intolerance to Treatment |
7.7 | — |
| SECONDARY Change From Baseline in MADRS Total Score After 52 Weeks of Treatment |
-7.35 | — |
| SECONDARY Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment |
-6.86 | — |
| SECONDARY Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment |
-5.44 | — |
| SECONDARY Change From Baseline in CGI-S Score After 52 Weeks of Treatment |
-1.00 | — |
| SECONDARY Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) |
94.2 | — |
| SECONDARY Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) |
83.0 | — |
| SECONDARY Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment |
2.74 | — |
| SECONDARY Change From Baseline in SDS Total Score After 52 Weeks of Treatment |
-5.60 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who completed 8-week short-term treatment study for Major Depressive Episode, NCT00635219 / 11984A
Exclusion Criteria
- Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Ed., Text revision (DSM-IV TR)
- Female patients of childbearing potential who are not using effective contraception
- Use of any psychoactive medication
Other protocol-defined inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00694304). 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.