Phase 3
Completed N=781
Efficacy of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
Source: ClinicalTrials.gov NCT00730691 ↗Enrolled (actual)
781
Serious AEs
0.6%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8 — -11.27; -12.23; -11.57; -11.66 scores on a scale — p=0.255
Summary
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8 |
-11.27; -12.23; -11.57; -11.66; -13.87 | 0.255 |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8 |
-4.00; -3.89; -4.24; -5.09; -5.54 | 0.830 |
| SECONDARY Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8 |
2.47; 2.36; 2.38; 2.38; 2.03 | 0.407 |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) at Week 8 |
-6.35; -6.15; -6.68; -7.95; -8.81 | 0.652 |
| SECONDARY Percentage of Responders in HAM-A Total Score at Week 8 |
42.2; 44.8; 42.6; 44.8; 51.0 | 0.641 |
| SECONDARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25 |
-11.61; -14.12; -13.87; -13.22; -16.15 | 0.064 |
| SECONDARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed |
-4.70; -4.56; -4.90; -5.04; -5.48; -7.30 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed |
-1.81; -1.85; -1.89; -2.22; -2.91; -3.24 | — |
| SECONDARY Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed |
3.44; 3.46; 3.41; 3.40; 3.36; 3.03 | — |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed |
-3.22; -2.74; -3.28; -4.11; -4.74; -4.53 | — |
| SECONDARY Percentage of Responders in HAM-A Total Score at Other Weeks Assessed |
11.3; 6.7; 8.5; 10.1; 16.8; 20.8 | — |
| SECONDARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 |
-5.32; -6.07; -5.96; -5.94; -6.78; -7.55 | — |
| SECONDARY Percentage of Participants in HAM-A Remission at Each Week Assessed |
4.0; 2.0; 0.7; 2.0; 4.9; 6.5 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S) |
-0.42; -0.37; -0.39; -0.42; -0.54; -0.71 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed |
-0.81; -0.83; -0.88; -1.25; -1.19; -1.32 | — |
| SECONDARY Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire |
34; 36; 26; 43; 38; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Has a primary diagnosis of generalized anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR®) criteria (classification code 300.02).
- Has a Hamilton Anxiety Scale total score ≥ 20. Has a Hamilton Anxiety Scale score ≥2 on both item 1 (anxious mood) and item 2 (tension).
- Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.
Exclusion Criteria
- Had received any investigational compound 1.5 times the upper limit of normal.
- Has a serum creatinine level >1.5 upper limit of normal.
- Has a previous history of cancer that had been in remission for less than 5 years.
- Hasclinically significant abnormal vital signs as determined by the investigator.
- Has a history of lack of response to previous adequate treatment with duloxetine for any Generalized Anxiety Disorder episode.
- Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit
- Has a thyroid stimulating hormone value outside the normal range.
- Has an abnormal electrocardiogram.
- has a disease or was taking medications that, in the opinion of the investigator, could have interfered with the assessments of safety, tolerability, or efficacy.
- The patient, in the opinion of the investigator, was unlikely to comply with the clinical study protocol or was unsuitable for any reason.
- Had previously been enrolled in this study.
Data sourced from ClinicalTrials.gov (NCT00730691). 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.