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

Major Depressive Disorder Clinical Trial

Official title:

A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of [Vortioxetine] Lu AA21004 (15 and 20 mg/Day) in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323478
• Other study ID #: 13267B
• Secondary ID: 2010-024198-38
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2011
• Last updated: December 23, 2013
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsEstonia: The State Agency of MedicineFinland: Finnish Medicines AgencyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthNorway: Norwegian Medicines AgencySlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSweden: Medical Products AgencyUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine (Lu AA21004)
15 or 20 mg/day; tablets; orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Events (AEs)		Baseline to end of the 4-week safety follow-up period	Yes
Primary	Percentage of Patients Who Withdrew Due to Intolerance to Treatment		Baseline to Week 52	Yes
Secondary	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.	Baseline and Week 52	No
Secondary	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.	Baseline and Week 52	No
Secondary	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.	Baseline and Week 52	No
Secondary	Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)		Baseline from lead-in study 13267A (NCT01140906) and Week 52	No
Secondary	Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)		Baseline and Week 52	No
Secondary	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.	Week 52	No
Secondary	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.	Week 52	Yes
Secondary	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.	Up to 52 weeks	Yes