Phase 3
Completed N=71
Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Source: ClinicalTrials.gov NCT01323478 ↗Enrolled (actual)
71
Serious AEs
1.4%
Results posted
Feb 2014
Primary outcomePrimary: Number of Patients With Adverse Events (AEs) — 56; 1; 7 participants
Summary
To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) |
56; 1; 7 | — |
| PRIMARY Percentage of Patients Who Withdrew Due to Intolerance to Treatment |
9.9 | — |
| SECONDARY Change From Baseline in MADRS Total Score After 52 Weeks of Treatment |
-10.9 | — |
| SECONDARY Change From Baseline in CGI-S Score After 52 Weeks of Treatment |
-1.49 | — |
| SECONDARY Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment |
-7.85 | — |
| SECONDARY Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score) |
93.6 | — |
| SECONDARY Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10) |
80.9 | — |
| SECONDARY SDS Total Score After 52 Weeks of Treatment |
4.85 | — |
| SECONDARY ASEX Total Score After 52 Weeks of Treatment |
18.60 | — |
| SECONDARY Risk of Suicidality Using C-SSRS Scores |
67; 0; 4; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
Patients who completed 8-week short-term treatment study, 13267A (NCT01140906), for Major Depressive Episode immediately prior to enrolment in this extension study
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
- The patient, in the investigator's clinical judgment, has a significant risk of suicide.
Other protocol-defined inclusion and exclusion criteria applied.
Data sourced from ClinicalTrials.gov (NCT01323478). 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.