Phase 3
Completed N=611
Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder
Source: ClinicalTrials.gov NCT00672620 ↗Enrolled (actual)
611
Serious AEs
1.2%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8 — -10.50; -12.04; -11.08; -13.47 scores on a scale — p=0.577
Summary
The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8 |
-10.50; -12.04; -11.08; -13.47 | 0.577 |
| SECONDARY Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed |
-5.12; -5.44; -5.28; -5.66; -7.19; -7.95 | — |
| SECONDARY Percentage of Responders in HAM-D 24 Total Score by Study Visit |
9.2; 8.4; 8.7; 10.2; 15.4; 17.1 | — |
| SECONDARY Percentage of Participants With a Sustained Response in HAM-D24 |
12.1; 15.8; 17.0; 21.5 | — |
| SECONDARY Percentage of Participants in MADRS Remission at Week 8 |
22.8; 28.8; 23.5; 37.6 | — |
| SECONDARY Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score |
-4.90; -5.16; -5.06; -5.49; -7.57; -7.71 | — |
| SECONDARY Clinical Global Impression Scale-Global Improvement Scale |
3.54; 3.42; 3.46; 3.31; 3.21; 3.17 | — |
| SECONDARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S) |
-2.51; -2.43; -2.74; -2.88; -4.02; -3.65 | — |
| SECONDARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score |
-2.63; -2.98; -2.55; -2.30; -3.82; -4.41 | — |
| SECONDARY Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale |
-0.28; -0.40; -0.37; -0.44; -0.63; -0.65 | — |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
-6.83; -6.46; -6.59; -8.91 | — |
| SECONDARY Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire |
40; 51; 42; 42; 4; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- The reported duration of the current major depressive episode is at least 3 months.
Exclusion Criteria
- Has 1 or more the following:
- Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
- Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
- Presence or history of a clinically significant neurological disorder (including epilepsy).
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- Any Axis II disorder that might compromise the study.
- Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
- The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- Has received electroconvulsive therapy within 6 months prior to Screening.
- Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Data sourced from ClinicalTrials.gov (NCT00672620). 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.