Phase 3
Completed N=836
Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Source: ClinicalTrials.gov NCT00707980 ↗Enrolled (actual)
836
Serious AEs
3.5%
Results posted
Dec 2013
Primary outcomePrimary: Physical Examination Findings — 758; 76; 484; 40 participants
Summary
The purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Examination Findings |
758; 76; 484; 40; 806; 28 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings |
3; 6; 1; 49; 80; 1 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings |
9; 0; 0; 13; 31; 2 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
589; 413; 176; 187; 320; 82 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Vital Sign Findings |
7; 4; 1; 8; 7; 2 | — |
| SECONDARY Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score |
-1.1; -3.1; -4.7; -6.5; -7.0; -7.7 | — |
| SECONDARY Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score |
-4.5; -7.9; -9.5; -7.4 | — |
| SECONDARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score |
-2.9; -5.1; -6.6; -5.2 | — |
| SECONDARY Change From Baseline in the Clinical Global Impression of Severity of Illness Scale |
-0.53; -0.98; -1.33; -1.00 | — |
| SECONDARY Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36) |
4.5; 8.1; 4.9; 6.4; 10.1; 10.9 | — |
| SECONDARY Change From Baseline to the Final Visit in the Sheehan Disability Scale |
-4.6 | — |
| SECONDARY Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire |
137; 4; 0; 53; 42; 138 | — |
Eligibility Criteria
Inclusion Criteria
- Has completed the double blind treatment period of either study Lu AA21004\_304 (NCT00672620) or LuAA21004\_305 (NCT00735709) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol).
- Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.xx) at entry into the prior Lu AA21004\_304 or Lu AA21004\_305 study.
Exclusion Criteria
- In addition to meeting the exclusion criteria for studies Lu AA21004\_304 or Lu AA21004\_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to Lu AA21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply:
- Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
- The participant, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale.
- The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
- Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
- Has used/uses disallowed concomitant medication.
Data sourced from ClinicalTrials.gov (NCT00707980). 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.