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

H. Lundbeck A/S71 enrolled

Overview

To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Vortioxetine (Lu AA21004)DRUG

15 or 20 mg/day; tablets; orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients who completed 8-week short-term treatment study, 13267A (NCT01140906), for Major Depressive Episode immediately prior to enrolment in this extension study Exclusion Criteria: * Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV TR) * Female patients of childbearing potential who are not using effective contraception * Use of any psychoactive medication * The patient, in the investigator's clinical judgment, has a significant risk of suicide. Other protocol-defined inclusion and exclusion criteria applied.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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 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

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

Data from ClinicalTrials.gov

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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

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

Time frame: Baseline and Week 52

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

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

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