The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 8-week acute treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
535
2.5, 5, or 10 mg/day; tablets; orally
Number of Patients With Adverse Events (AEs)
Time frame: Baseline to end of the 4-week safety follow-up period
Percentage of Patients Who Withdrew Due to Intolerance to Treatment
Time frame: Baseline to Week 52
Change From Baseline in MADRS Total Score After 52 Weeks of Treatment
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.
Time frame: Baseline and Week 52
Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment
The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
Time frame: Baseline and Week 52
Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour 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 score from 0 to 56. The higher the score, the more severe.
Time frame: Baseline and Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change From Baseline in CGI-S Score After 52 Weeks of Treatment
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.
Time frame: Baseline and Week 52
Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)
Time frame: Week 52
Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)
Time frame: Week 52
Proportion of Patients With a MADRS Total Score >=22 After 52 Weeks of Treatment
Time frame: Baseline and Week 52
Change From Baseline in SDS Total Score After 52 Weeks of Treatment
The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.
Time frame: Baseline and Week 52