A Phase 3 Study of Lu AA21004 in Patients With Major Depressive Disorder
Summary
The purpose of this study is to evaluate the efficacy of two fixed doses of vortioxetine (Lu AA21004; 10 or 20 mg/day) after 8 weeks of treatment in patients with major depressive disorder (MDD) in Japan.
Timeline
- Start
- 2015-04-10
- Primary completion
- 2018-03-16
- Completion
- 2018-03-16
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Vortioxetine 10 mg; p = 0.0080; Least square (LS) mean difference -2.66 (95% CI -4.63 to -0.70); Mixed Models Analysis NCT02389816 ↗
registry analysis (superiority test); Placebo vs Vortioxetine 20 mg; p = 0.0023; LS mean difference -3.07 (95% CI -5.05 to -1.10); Mixed Models Analysis NCT02389816 ↗
release “The study demonstrated positive results of vortioxetine including the primary endpoint as compared to placebo for the treatment of MDD in adults.” takeda.com ↗
Publications
- Watanabe K, Fujimoto S, Marumoto T, Kitagawa T, Ishida K, Nakajima T, Moriguchi Y, Fujikawa K, Inoue T. Therapeutic Potential of Vortioxetine for Anhedonia-Like Symptoms in Depression: A Post Hoc Analysis of Data from a Clinical Trial Conducted in Japan. Neuropsychiatr Dis Treat. 2022 Feb 19;18:363-373. doi: 10.2147/NDT.S340281. eCollection 2022.
- Inoue T, Fujimoto S, Marumoto T, Kitagawa T, Ishida K, Nakajima T, Moriguchi Y, Fujikawa K, Watanabe K. Therapeutic Potential of Vortioxetine for Anxious Depression: A Post Hoc Analysis of Data from a Clinical Trial Conducted in Japan. Neuropsychiatr Dis Treat. 2021 Dec 21;17:3781-3790. doi: 10.2147/NDT.S335028. eCollection 2021.
- Inoue T, Fujimoto S, Marumoto T, Kitagawa T, Ishida K, Nakajima T, Moriguchi Y, Fujikawa K, Watanabe K. Early Improvement with Vortioxetine Predicts Response and Remission: A Post Hoc Analysis of Data from a Clinical Trial Conducted in Japan. Neuropsychiatr Dis Treat. 2021 Dec 18;17:3735-3741. doi: 10.2147/NDT.S340309. eCollection 2021.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vortioxetine | Unknown | 10 mg | Oral |
| Subject | Vortioxetine | Unknown | 20 mg | Oral |