Phase 2
Completed N=74
Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Source: ClinicalTrials.gov NCT00761306 ↗Enrolled (actual)
74
Serious AEs
1.4%
Results posted
Dec 2013
Primary outcomePrimary: Number of Patients With Adverse Events (AEs) — 64; 1; 5; 16 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 6-week acute treatment in study NCT00839423 / 11492A.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) |
64; 1; 5; 16 | — |
| PRIMARY Percentage of Patients Who Withdrew Due to Intolerance to Treatment |
6.8 | — |
| SECONDARY Change From Baseline in MADRS Total Score After 52 Weeks of Treatment |
-4.33 | — |
| SECONDARY Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment |
-3.46 | — |
| SECONDARY Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) |
92.7 | — |
| SECONDARY Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) |
81.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who completed 6-week short-term treatment study for Major Depressive Episode (MDE), NCT00839423 / 11492A, followed by a 2-week taper period
Exclusion Criteria
- Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, 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 (NCT00761306). 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.