Phase 3
Completed N=469
Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT01179516 ↗
Enrolled (actual)
469
Serious AEs
0.4%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -12.87; -13.66; -13.36 scores on a scale — p=0.597
Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
-12.87; -13.66; -13.36 | 0.597 |
| SECONDARY Percentage of Participants With a MADRS Response at Week 8 |
32.9; 37.8; 37.3 | 0.396 |
| SECONDARY Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8 |
2.65; 2.56; 2.60 | 0.554 |
| SECONDARY Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥ 20 |
-14.11; -15.07; -12.37 | 0.670 |
| SECONDARY Percentage of Participants in MADRS Remission at Week 8 |
22.1; 26.6; 23.9 | 0.352 |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Score |
-9.38; -10.30; -8.69 | 0.464 |
Eligibility Criteria
Inclusion Criteria
- Suffers from a major depressive episode (MDE) recurrent as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
- The reported duration of the current MDE is at least 3 months.
- Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
- Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.
Exclusion Criteria
- Has received any investigational compound 1.5 times the upper limits of normal (× ULN).
- A total serum total bilirubin value >1.5 × ULN.
- A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 × ULN.
- Has a thyroid stimulating hormone value outside the normal range.
- Has clinically significant abnormal vital signs.
- Has an abnormal electrocardiogram.
Data sourced from ClinicalTrials.gov (NCT01179516). 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.