Phase 3
Completed N=639
Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes
Source: ClinicalTrials.gov NCT00596817 ↗Enrolled (actual)
639
Serious AEs
2.6%
Results posted
Mar 2014
Primary outcomePrimary: Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator — 26.0; 13.2 percentage of patients who relapsed — p=0.0035
Summary
This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator |
26.0; 13.2 | 0.0035 sig |
| SECONDARY Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator |
30.2; 15.2 | 0.0010 sig |
| SECONDARY Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment |
1.45; -0.62 | 0.0020 sig |
| SECONDARY Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment |
1.61; 0.30 | 0.0171 sig |
| SECONDARY Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment |
0.89; -0.23 | 0.0612 |
| SECONDARY Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment |
0.24; -0.14 | 0.0002 sig |
| SECONDARY Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline) |
91.7; 98.0 | 0.025 sig |
| SECONDARY Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10) |
82.6; 94.7 | 0.002 sig |
| SECONDARY Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period |
0.14; -0.53 | 0.3642 |
Eligibility Criteria
Inclusion Criteria
- Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
- At least one other MDE before the current one
- Moderate to severe depression
Exclusion Criteria
- Any current psychiatric disorder other than Major Depressive Disorder (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
Randomisation Criteria: Patients in remission (MADRS total score <=10) at both Week 10 and Week 12
Other protocol-defined inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00596817). 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.