A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- Vortioxetine
- Conditions
- Major Depressive Disorder
- Sponsor
- Takeda
- Enrollment
- 611
- Primary Endpoint
- Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.
Detailed Description
The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine. The study enrolled 611 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Vortioxetine 2.5 mg * Vortioxetine 5 mg * Duloxetine 10 mg * Placebo (dummy inactive capsule) - 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 the United States. The overall time to participate in this study was up to 12 weeks. Participants made 8 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 major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
- •The reported duration of the current major depressive episode is at least 3 months.
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.
- •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.
- •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 (MADRS) or has made a suicide attempt in the previous 6 months.
- •The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- •Has received electroconvulsive therapy within 6 months prior to Screening.
Arms & Interventions
Vortioxetine 2.5 mg
Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
Intervention: Vortioxetine
Vortioxetine 5 mg
Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
Intervention: Vortioxetine
Duloxetine 60 mg
Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsules, orally, once daily for 1 week after the treatment period.
Intervention: Duloxetine
Placebo
Placebo-matching capsules, orally, once daily for up to 9 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Week 8
Time Frame: Baseline and Week 8
The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with terms for treatment and center as factors and the Baseline rank value as a covariate.
Secondary Outcomes
- Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed(Baseline and Weeks 1, 2, 4, and 6)
- Percentage of Responders in HAM-D 24 Total Score by Study Visit(Baseline and Weeks 1, 2, 4, 6 and 8.)
- Percentage of Participants With a Sustained Response in HAM-D24(Baseline to Week 8)
- Percentage of Participants in MADRS Remission at Week 8(Week 8)
- Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score(Baseline and Weeks 1, 2, 4, 6 and 8)
- Clinical Global Impression Scale-Global Improvement Scale(Baseline and Weeks 1, 2, 4, 6 and 8.)
- Change From Baseline in Montgomery-Åsberg Depression Rating Scale - Self-assessment (MADRS-S)(Baseline and Weeks 1, 4 and 8)
- Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire(Baseline and Week 8)
- Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score(Baseline and Weeks 1, 2, 4, 6 and 8.)
- Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8(Baseline and Week 8)
- Change From Baseline in the Clinical Global Impression Scale-Severity of Illness Scale(Baseline and Weeks 1, 2, 4, 6 and 8.)