Phase 3
Completed N=304
An Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Treating Generalized Anxiety Disorder
Source: ClinicalTrials.gov NCT00734071 ↗Enrolled (actual)
304
Serious AEs
1.3%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 — -13.16; -12.57 scores on a scale — p=0.518
Summary
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in treating Generalized Anxiety Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 |
-13.16; -12.57 | 0.518 |
| SECONDARY Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8 |
-4.84; -5.06 | 0.685 |
| SECONDARY Clinical Global Impression Scale-Global Improvement at Week 8 |
2.25; 2.25 | 0.984 |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8 |
-6.68; -6.35 | 0.703 |
| SECONDARY Percentage of Responders in HAM-A Total Score at Week 8 |
50.0; 53.1 | 0.602 |
| SECONDARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25 |
-14.04; -14.05 | 0.995 |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8 |
17.43; 18.44 | 0.731 |
| SECONDARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed |
-4.84; -4.59; -7.78; -8.22; -10.13; -9.82 | — |
| SECONDARY Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed |
-1.81; -2.07; -3.41; -3.72 | — |
| SECONDARY Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed |
3.32; 3.38; 2.92; 2.83; 2.57; 2.57 | — |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed |
-2.13; -2.46; -4.35; -4.02; -5.57; -5.38 | — |
| SECONDARY Percentage of Responders in HAM-A Total Score at Other Weeks Assessed |
9.9; 6.9; 22.9; 24.1; 34.7; 37.2 | — |
| SECONDARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25 |
-5.39; -4.73; -8.37; -8.94; -10.90; -10.74 | — |
| SECONDARY Percentage of Participants in HAM-A Remission at Each Week Assessed |
2.1; 0.7; 5.6; 7.6; 15.3; 12.4 | — |
| SECONDARY Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed |
-0.37; -0.38; -0.75; -0.86; -1.15; -1.05 | — |
| SECONDARY Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed |
-1.02; -1.09; -1.84; -2.28; -2.55; -2.62 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed |
11.96; 14.06; 17.12; 16.22 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed |
1.54; 3.69; 4.76; 4.22; 3.50; 4.18 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed |
5.03; 4.90; 8.65; 5.19; 10.02; 7.74 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed |
7.24; 6.49; 9.81; 8.96; 10.14; 8.58 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed |
2.79; 3.61; 4.85; 1.76; 6.14; 3.90 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed |
8.91; 10.46; 12.48; 12.67; 16.06; 14.65 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed |
14.54; 13.25; 16.00; 15.00; 21.64; 19.01 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed |
10.32; 11.72; 12.58; 15.12; 17.95; 16.91 | — |
| SECONDARY Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire |
30; 30; 1; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Has a primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria.
- Has a Hamilton Anxiety Scale total score greater than or equal to 20 at Screening and Baseline.
- Has a Hamilton Anxiety Scale score greater than or equal to 2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
- Has a Montgomery-Åsberg Depression Rating Scale total score less than or equal to 16 at Screening and Baseline.
Exclusion Criteria
- Has 1 or more of the following:
- Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview [MINI]).
- 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® and subject must have a 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.).
- Any Axis II disorder that might compromise the study.
- Is taking excluded medications.
- Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on Item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
- 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.
- Is 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 an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level greater than 1.5 times the upper limit of normal.
- Has a serum creatinine of greater than 1.5 times the 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 at Screening and is deemed clinically significant by the investigator.
- Has an abnormal electrocardiogram.
Data sourced from ClinicalTrials.gov (NCT00734071). 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.