Phase 3
Completed N=452
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients
Source: ClinicalTrials.gov NCT00811252 ↗Enrolled (actual)
452
Serious AEs
1.3%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment — -10.3; -13.7; -15.8 units on a scale — p=0.0011
Summary
To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item Hamilton Depression Scale (HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment |
-10.3; -13.7; -15.8 | 0.0011 sig |
| SECONDARY Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment |
-10.2; -12.3; -14.4 | 0.0240 sig |
| SECONDARY Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment |
-8.99; -10.1; -12.3 | 0.2134 |
| SECONDARY Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment |
-6.66; -6.95; -7.91 | 0.6879 |
| SECONDARY Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment |
-3.62; -4.04; -3.48 | 0.4482 |
| SECONDARY Change From Baseline in MADRS Total Score After 8 Weeks of Treatment |
-11.2; -15.5; -18.0 | <0.0001 sig |
| SECONDARY Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment |
-5.74; -8.09; -9.28 | 0.0015 sig |
| SECONDARY Change From Baseline in CGI-S Score After 8 Weeks of Treatment |
-1.03; -1.63; -2.05 | <0.0001 sig |
| SECONDARY Change in Clinical Status Using CGI-I Score at Week 8 |
2.91; 2.35; 2.07 | <0.0001 sig |
| SECONDARY Change From Baseline in GDS Total Score After 8 Weeks of Treatment |
-0.65; -1.08; -1.32 | 0.0552 |
| SECONDARY Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score) |
35; 53; 63 | 0.0008 sig |
| SECONDARY Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) |
21; 34; 47 | 0.0090 sig |
| SECONDARY Risk of Suicidality Using C-SSRS Scores |
103; 107; 106; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
Clinical Diagnosis of recurrent Major Depressive Episode (MDE) according the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria with:
- Reported duration of the current episode of at least 4 weeks
- MADRS total score >=26
- At least one previous MDE before the age of 60 years
Exclusion Criteria
- Mini Mental State Exam (MMSE) =5 on item 10 of the MADRS or has made a suicide attempt in the previous 6 months
Other inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00811252). 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.