Phase 3
Completed N=301
Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.
Source: ClinicalTrials.gov NCT00744627 ↗Enrolled (actual)
301
Serious AEs
0.3%
Results posted
Mar 2014
Primary outcomePrimary: Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 — -10.49; -14.30 scores on a scale — p=<0.001
Summary
The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily (QD), in adults with Generalized Anxiety Disorders.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 |
-10.49; -14.30 | <0.001 sig |
| SECONDARY Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8 |
-4.20; -6.49 | <0.001 sig |
| SECONDARY Clinical Global Impression Scale-Global Improvement at Week 8 |
2.66; 2.19 | <0.001 sig |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
-6.14; -8.10 | 0.031 sig |
| SECONDARY Percentage of Responders in HAM-A Total Score at Week 8 |
39.9; 61.7 | <0.001 sig |
| SECONDARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25 |
-10.44; -15.55 | <0.001 sig |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8 |
18.02; 26.80 | 0.002 sig |
| SECONDARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed |
-2.46; -2.50; -5.05; -6.21; -7.43; -9.62 | — |
| SECONDARY Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed |
-1.42; -1.14; -3.13; -4.07 | — |
| SECONDARY Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed |
3.58; 3.67; 3.31; 3.10; 2.99; 2.66 | — |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed |
-1.32; -1.12; -2.93; -3.04; -4.35; -5.13 | — |
| SECONDARY Percentage of Responders in HAM-A Total Score at Other Weeks Assessed |
2.7; 2.0; 12.2; 12.1; 20.3; 28.9 | — |
| SECONDARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 |
-2.64; -2.62; -4.89; -6.43; -7.33; -10.08 | — |
| SECONDARY Percentage of Participants in HAM-A Remission at Each Week Assessed |
0; 0; 2.7; 2.7; 6.8; 8.7 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed |
-0.23; -0.19; -0.53; -0.60; -0.87; -1.04 | — |
| SECONDARY Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed |
-0.18; -0.28; -1.08; -1.62; -1.50; -3.18 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed |
8.50; 8.83; 11.41; 18.45 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed |
2.54; 3.39; 2.15; 8.34; 4.48; 10.69 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed |
4.72; 5.99; 6.89; 11.89; 8.96; 18.39 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed |
6.49; 7.40; 6.81; 10.62; 10.90; 15.38 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed |
4.54; 6.04; 8.45; 10.36; 9.76; 16.30 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed |
5.44; 8.11; 8.36; 13.38; 12.56; 22.53 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed |
7.27; 9.62; 13.41; 19.04; 18.96; 28.13 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed |
5.58; 8.90; 9.79; 14.73; 13.51; 21.75 | — |
| SECONDARY Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire |
79; 84; 7; 3; 4; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Suffers from a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
- Has a Hamilton Anxiety Scale total score ≥20 at Screening and Baseline.
- Has a Hamilton Anxiety Scale score ≥2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
- Has a Montgomery-Åsberg Depression Rating Scale total score ≤16 at Screening and Baseline.
- Male and females of childbearing potential who are sexually active agree 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 received any investigational compound 1.5 times the upper limits of normal.
- Has a serum creatinine of >1.5 times the upper limits of normal.
- Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those participants with basal cell or stage I squamous cell carcinoma of the skin.
- Has clinically significant abnormal vital signs as determined by the investigator.
- Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at Screening, that are considered by the investigator to be clinically significant.
- Has thyroid stimulating hormone value outside the normal range at Screening and is deemed clinically significant by the investigator.
- Has an abnormal electrocardiogram as determined by the central reader and confirmed as clinically significant by the investigator.
- Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
- Has previously participated in this study.
Data sourced from ClinicalTrials.gov (NCT00744627). 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.