Phase 3
Completed N=607
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Source: ClinicalTrials.gov NCT01140906 ↗Enrolled (actual)
607
Serious AEs
0.8%
Results posted
Feb 2014
Primary outcomePrimary: Change From Baseline in MADRS Total Score After 8 Weeks of Treatment. — -11.70; -17.23; -18.79; -21.15 units on a scale — p=<0.0001
Summary
The purpose of the study is to evaluate the efficacy, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in MADRS Total Score After 8 Weeks of Treatment. |
-11.70; -17.23; -18.79; -21.15 | <0.0001 sig |
| SECONDARY Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) |
32; 57; 62; 74 | <0.0001 sig |
| SECONDARY Change in Clinical Status Using CGI-I Score at Week 8 |
2.86; 2.18; 1.92; 1.75 | <0.0001 sig |
| SECONDARY Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20 |
-12.20; -17.44; -18.62; -20.91 | 0.0007 sig |
| SECONDARY Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) |
19; 35; 38; 54 | 0.0016 sig |
| SECONDARY Change From Baseline in SDS Total Score After 8 Weeks of Treatment |
-4.46; -7.70; -8.38; -11.39 | 0.0054 sig |
| SECONDARY Change From Baseline in ASEX Total Score After 8 Weeks of Treatment |
0.28; -0.39; -0.20; -1.25 | 0.2524 |
| SECONDARY Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine |
0.15; 0.01; 0.72; 2.28 | 0.7372 |
Eligibility Criteria
Inclusion Criteria
- The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x)
- The patient has a MADRS total score >=26
- The patient has a CGI-S score >=4
- The patient has had the current episode of MDE for >3 months
Exclusion Criteria
- Any current anxiety psychiatric disorder as defined in the DSM-IV TR
- Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV TR
- Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR
- Use of any psychoactive medication 2 weeks prior to screening and during the study
- The patient is at significant risk of suicide or has a score >=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit
Other protocol-defined inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01140906). 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.