Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT00839423
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 426
- MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
- Current MDE duration of at least 3 months and less than 12 months
- The patient has a MADRS total score >=30
- Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- Any substance disorder within the previous 6 months
- Female patients of childbearing potential who are not using effective contraception
- Use of any psychoactive medication 2 weeks prior to screening and during the study
Other protocol-defined inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Vortioxetine (Lu AA21004) 5 mg Vortioxetine (Lu AA21004) - Vortioxetine (Lu AA21004) 10 mg Vortioxetine (Lu AA21004) - Venlafaxine XL 225 mg Venlafaxine XL Active Reference
- Primary Outcome Measures
Name Time Method Change From Baseline in MADRS Total Score After 6 Weeks of Treatment Baseline and Week 6 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in CGI-S Score After 6 Weeks of Treatment Baseline and Week 6 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.
Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10) Week 6 Change From Baseline in MADRS Total Score After 1 Week of Treatment Baseline and Week 1 Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment Baseline and Week 6 The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.
Change in Clinical Status Using CGI-I Score at Week 6 Week 6 The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.
Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) Week 6 Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment Baseline and Week 6 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.