Phase 3
Completed N=766
Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder
Source: ClinicalTrials.gov NCT00635219 ↗Enrolled (actual)
766
Serious AEs
1.4%
Results posted
Feb 2014
Primary outcomePrimary: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment — -14.8; -16.2; -16.5; -16.3 units on a scale — p=0.1321
Summary
The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder (MDD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in MADRS Total Score After 8 Weeks of Treatment |
-14.8; -16.2; -16.5; -16.3; -16.8 | 0.1321 |
| SECONDARY Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment |
-13.3; -14.4; -15.0; -14.9; -15.7 | 0.1120 |
| SECONDARY Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) |
46.9; 54.2; 56.1; 57.6; 57.1 | 0.1370 |
| SECONDARY Change in Clinical Status Using CGI-I Score at Week 8 |
2.52; 2.32; 2.32; 2.35; 2.31 | 0.1436 |
| SECONDARY Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 |
-14.7; -14.3; -15.8; -15.8; -17.3 | 0.4421 |
| SECONDARY Change From Baseline in SDS Total Score After 8 Weeks of Treatment |
-6.11; -7.10; -6.52; -7.81; -7.91 | 0.6748 |
| SECONDARY Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) |
33.8; 32.9; 36.1; 35.8; 34.9 | 0.6258 |
| SECONDARY Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment |
-9.57; -9.87; -10.7; -10.6; -11.0 | 0.1925 |
| SECONDARY Change From Baseline in CGI-S Score After 8 Weeks of Treatment |
-1.64; -1.83; -1.81; -1.83; -1.82 | 0.2285 |
| SECONDARY Change From Baseline in ASEX Total Score After 8 Weeks of Treatment |
-0.41; -0.53; -0.66; -0.62; -0.38 | 0.7789 |
Eligibility Criteria
Inclusion Criteria
- MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
- Moderate to severe depression
- Current MDE duration of at least 3 months
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 (NCT00635219). 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.