Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries

October 6, 2014 updated by: H. Lundbeck A/S

Randomised, Double-blind, Parallel-group, Active-comparator (Venlafaxine Extended Release), Fixed-dose Study of [Vortioxetine] Lu AA21004 in Major Depressive Disorder in Asian Countries

This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

437

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
  • The patient has a MADRS total score ≥26
  • The patient has a CGI-S score ≥4
  • The reported duration of the current MDE is ≥3 months.

Other inclusion criteria may apply.

Exclusion Criteria:

- The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vortioxetine (Lu AA21004)
Drug: Vortioxetine (Lu AA21004)
10 mg/day
Other Names:
  • Brintellix
Active Comparator: Venlafaxine extended release
Drug: Venlafaxine extended release
150 mg/day
Other Names:
  • Efexor® XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in MADRS Total Score at Week 8
Time Frame: Baseline and Week 8
Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CGI-S Score From Baseline to Week 8
Time Frame: Baseline and Week 8
Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Baseline and Week 8
CGI-I Score at Week 8
Time Frame: Week 8
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.
Week 8
Change in HAM-A Total Score From Baseline to Week 8
Time Frame: Baseline and Week 8
Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Baseline and Week 8
MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)
Time Frame: Week 8
Week 8
Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)
Time Frame: Week 8
Week 8
Number of Adverse Events
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Estimate)

October 13, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13926A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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