Phase 2
Completed N=426
Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Source: ClinicalTrials.gov NCT00839423 ↗Enrolled (actual)
426
Serious AEs
0.7%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment — -14.50; -20.40; -20.20; -20.92 units on a scale — p=<0.0001
Summary
The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in MADRS Total Score After 6 Weeks of Treatment |
-14.50; -20.40; -20.20; -20.92 | <0.0001 sig |
| SECONDARY Change From Baseline in MADRS Total Score After 1 Week of Treatment |
-5.04; -5.26; -5.86; -4.50 | 0.2377 |
| SECONDARY Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment |
-12.23; -17.51; -17.57; -17.32 | <0.0001 sig |
| SECONDARY Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment |
-8.41; -11.71; -11.41; -11.29 | 0.0011 sig |
| SECONDARY Change From Baseline in CGI-S Score After 6 Weeks of Treatment |
-1.55; -2.45; -2.51; -2.58 | <0.0001 sig |
| SECONDARY Change in Clinical Status Using CGI-I Score at Week 6 |
2.64; 2.05; 2.04; 1.96 | 0.0003 sig |
| SECONDARY Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) |
44.8; 66.7; 68.0; 72.3 | 0.002 sig |
| SECONDARY Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10) |
26.7; 49.1; 49.0; 55.4 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
- Current MDE duration of at least 3 months and less than 12 months
- The patient has a MADRS total score >=30
Exclusion Criteria
- Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- Any substance disorder within the previous 6 months
- Female patients of childbearing potential who are not using effective contraception
- Use of any psychoactive medication 2 weeks prior to screening and during the study
Other protocol-defined inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00839423). 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.