Phase 3
Completed N=560
Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
Source: ClinicalTrials.gov NCT00735709 ↗Enrolled (actual)
560
Serious AEs
1.1%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8 — -11.30; -14.82; -15.42; -16.23 scores on a scale — p=<0.001
Summary
The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients 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 |
-11.30; -14.82; -15.42; -16.23 | <0.001 sig |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
-6.54; -6.58; -7.65; -8.08 | 0.135 |
| SECONDARY Clinical Global Impression Scale-Global Improvement at Week 8 |
2.84; 2.37; 2.37; 2.29 | <0.001 sig |
| SECONDARY Percentage of Responders in HAM-D24 Total Score at Week 8 |
23.0; 47.5; 45.3; 49.6 | <0.001 sig |
| SECONDARY Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20 |
-11.02; -15.16; -15.50; -15.61 | 0.001 sig |
| SECONDARY Percentage of Participants in MADRS Remission at Week 8 |
16.5; 25.9; 28.8; 26.6 | 0.026 sig |
| SECONDARY Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed |
-3.47; -2.81; -3.20; -3.20; -5.66; -7.27 | — |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed |
-1.22; -1.13; -1.78; -1.43; -2.53; -3.44 | — |
| SECONDARY Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed |
3.65; 3.71; 3.67; 3.64; 3.40; 3.16 | — |
| SECONDARY Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed |
0.7; 0.7; 0.7; 1.4; 5.0; 7.9 | — |
| SECONDARY Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20 |
-3.79; -2.94; -3.55; -3.19; -5.76; -7.21 | — |
| SECONDARY Percentage of Participants in MADRS Remission at Other Weeks Assessed |
0.7; 0.7; 0; 0; 2.2; 2.2 | — |
| SECONDARY Percentage of Participants With a Sustained Response in HAM-D24 Total Score |
10.1; 9.4; 10.1; 10.8 | — |
| SECONDARY Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week |
-2.90; -2.55; -2.66; -2.57; -4.92; -6.65 | — |
| SECONDARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed |
-1.58; -1.27; -1.41; -1.56; -3.06; -3.72 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed |
-0.24; -0.20; -0.22; -0.24; -0.46; -0.58 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed |
-0.46; -1.14; -0.87; -0.91; -1.95; -2.83 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed |
2.24; 5.39; 7.55; 3.34; 5.10; 7.77 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed |
0.74; 6.09; 7.38; 5.00; 4.53; 10.62 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed |
2.99; 5.06; 4.52; 7.22; 4.45; 5.33 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed |
2.83; 5.54; 5.64; 5.47; 6.51; 8.98 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed |
5.97; 10.39; 8.83; 8.03; 12.06; 16.69 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed |
6.38; 9.71; 12.02; 10.03; 12.34; 15.71 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed |
6.84; 8.78; 10.87; 9.93; 12.05; 17.01 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed |
6.98; 10.62; 9.56; 10.26; 13.06; 16.78 | — |
| SECONDARY Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire. |
62; 64; 71; 61; 4; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
- The reported duration of the current major depressive episode is at least 3 months.
- Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.
- A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.
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. (must have negative urine drug screen prior to Baseline).
- Presence or history of a clinically significant neurological disorder (including epilepsy).
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
- 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, or has made a suicide attempt in the previous 6 months.
- Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
- Has a clinically significant unstable illness.
- Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
- Has received electroconvulsive therapy within 6 months prior to Screening.
- Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.
- Has a serum creatinine of > 1.5 × upper limit of normal.
- Has a previous history of cancer that had been in remission for less than 5 years.
- Has thyroid stimulating hormone value outside the normal range.
- Has an abnormal electrocardiogram.
Data sourced from ClinicalTrials.gov (NCT00735709). 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.