Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

Browse trials for

• Depressive Disorder 4,845
• Depression 8,057
• Depressive Disorder, Major 2,741

Keywords

• Depressive Disorder
• Depression
• Depressive Disorder, Major
• Mood Disorders
• Mental Disorders
• Behavioural Symptoms

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 71 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Study arms

• Experimental
  Vortioxetine

  Drug: Vortioxetine (Lu AA21004)

Interventions

• DrugVortioxetine (Lu AA21004)

  15 or 20 mg/day; tablets; orally

  Also known as: Brintellix

Primary outcomes

1. Number of Patients With Adverse Events (AEs)

   Time frame: Baseline to end of the 4-week safety follow-up period

2. Percentage of Patients Who Withdrew Due to Intolerance to Treatment

   Time frame: Baseline to Week 52

Secondary outcomes

1. 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

2. 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

3. 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

4. Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)

   Time frame: Baseline from lead-in study 13267A (NCT01140906) and Week 52

5. Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)

   Time frame: Baseline and Week 52

6. 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: Week 52

7. ASEX Total Score After 52 Weeks of Treatment

   The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction.

   Time frame: Week 52

8. Risk of Suicidality Using C-SSRS Scores

   The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient. Different versions of the C-SSRS are available. In this study, the Since Last Visit Version was used at all visits. In order to assess the potential relationship between Vortioxetine and suicidality more accurately and systematically, C-SSRS data were collected during the Entire Study Period.

   Time frame: Up to 52 weeks

Baseline characteristics