Phase 3
Completed N=495
A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication
Source: ClinicalTrials.gov NCT01488071 ↗Enrolled (actual)
495
Serious AEs
1.4%
Results posted
Mar 2014
Primary outcomePrimary: Change From Baseline in MADRS Total Score at Week 8 — -16.53; -14.38 units on a scale — p=0.0018
Summary
The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in MADRS Total Score at Week 8 |
-16.53; -14.38 | 0.0018 sig |
| SECONDARY Change From Baseline in MADRS Total Score at Week 12 |
-18.95; -16.92 | 0.0054 sig |
| SECONDARY Change From Baseline in HAM-A Total Score at Week 8 |
-11.68; -9.79 | 0.0008 sig |
| SECONDARY Change From Baseline in HAM-A Total Score at Week 12 |
-13.52; -11.59 | 0.0007 sig |
| SECONDARY Change From Baseline in CGI-S Score at Week 8 |
-1.84; -1.55 | 0.0023 sig |
| SECONDARY Change From Baseline in CGI-S Score at Week 12 |
-2.20; -1.93 | 0.0075 sig |
| SECONDARY Change in Clinical Status Using CGI-I Score at Week 8 |
1.97; 2.22 | 0.0048 sig |
| SECONDARY Change in Clinical Status Using CGI-I Score at Week 12 |
1.74; 1.99 | 0.0055 sig |
| SECONDARY Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) |
61.5; 47.3 | 0.0012 sig |
| SECONDARY Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) |
69.8; 56.0 | 0.0014 sig |
| SECONDARY Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10) |
40.5; 29.5 | 0.0054 sig |
| SECONDARY Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10) |
55.2; 39.4 | 0.0002 sig |
| SECONDARY Change From Baseline in SDS Total Score at Week 8 |
-9.28; -7.06 | 0.0021 sig |
| SECONDARY Change From Baseline in SDS Total Score at Week 12 |
-10.99; -9.24 | 0.0209 sig |
Eligibility Criteria
Inclusion Criteria
- The patient is being treated with a serotonin reuptake inhibitor (SRI) antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)
- The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline
- Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥22 at the Screening Visit and Baseline
- The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception
Exclusion Criteria
- The patient has any current Axis I disorders (DSM-IV criteria) other than Major Depressive Disorder (MDD), General Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD)
- The patient is at significant risk of suicide
- The patient is currently receiving formal psychotherapy or other psychoactive medications
Other protocol-defined inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01488071). 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.