Phase 3
N=437
Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01571453 ↗Enrolled (actual)
437
Serious AEs
2.3%
Results posted
Oct 2014
Primary outcome: Primary: Change From Baseline in MADRS Total Score at Week 8 — -19.36; -18.16 units on a scale — p=0.199
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vortioxetine (Lu AA21004) (Drug); Venlafaxine extended release (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lundbeck A/S
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in MADRS Total Score at Week 8 |
-19.36; -18.16 | 0.199 |
| SECONDARY Change in CGI-S Score From Baseline to Week 8 |
-2.26; -2.12 | 0.228 |
| SECONDARY CGI-I Score at Week 8 |
1.99; 2.14 | 0.174 |
| SECONDARY Change in HAM-A Total Score From Baseline to Week 8 |
-11.38; -10.56 | 0.207 |
| SECONDARY MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline) |
66.5; 61.4 | 0.272 |
| SECONDARY Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10) |
43.1; 41.4 | 0.731 |
| SECONDARY Number of Adverse Events |
— | — |
Summary
This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).
Eligibility Criteria
Inclusion Criteria
- The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
- The patient has a MADRS total score ≥26
- The patient has a CGI-S score ≥4
- The reported duration of the current MDE is ≥3 months.
Other inclusion criteria may apply.
Exclusion Criteria
- The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.
Data sourced from ClinicalTrials.gov (NCT01571453). 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.