A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of a Single Dose of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder
Overview
- Phase
- Phase 3
- Intervention
- Vortioxetine
- Conditions
- Generalized Anxiety Disorder
- Sponsor
- Takeda
- Enrollment
- 301
- Primary Endpoint
- Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily (QD), in adults with Generalized Anxiety Disorders.
Detailed Description
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine. The study enrolled 301 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Vortioxetine 5 mg * Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient. All participants were asked to take one capsule at the same time each day throughout the study. This multi-center trial was conducted in Europe. The overall time to participate in this study was up to 13 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
Investigators
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 \<30 days before Screening or 5 half-lives prior to Screening.
- •Has received Lu AA21004 in a previous clinical study or as a therapeutic agent.
- •Has 1 or more of the following:
- •Any current psychiatric disorder other than Generalized Anxiety 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's disease, Parkinson's disease, multiple sclerosis, Huntington disease, etc).
- •Any Axis II disorder that might compromise the study.
- •Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study including:
Arms & Interventions
Vortioxetine 5 mg
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
Intervention: Vortioxetine
Placebo
Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8
Time Frame: Baseline to Week 8
The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.
Secondary Outcomes
- Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8(Baseline to Week 8)
- Clinical Global Impression Scale-Global Improvement at Week 8(Baseline to Week 8)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8(Baseline to Week 8)
- Percentage of Responders in HAM-A Total Score at Week 8(Baseline and Week 8)
- Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25(Baseline to Week 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8(Baseline to Week 8)
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed(Baseline to Weeks 1, 2, 4 and 6.)
- Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed(Baseline to Weeks 1 and 4)
- Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed(Baseline to Weeks 1, 2, 4 and 6)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed(Baseline to Weeks 1, 2 and 4)
- Percentage of Responders in HAM-A Total Score at Other Weeks Assessed(Baseline and Weeks 1, 2, 4 and 6)
- Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25(Baseline to Weeks 1, 2, 4 and 6)
- Percentage of Participants in HAM-A Remission at Each Week Assessed(Weeks 1, 2, 4, 6 and 8)
- Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed(Baseline to Weeks 1, 2, 4, 6 and 8)
- Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed(Baseline to Weeks 1, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed(Baseline to Weeks 2 and 4)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed(Baseline to Weeks 2, 4 and 8)
- Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire(Baseline and Week 8)