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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01571453
First received: March 28, 2012
Last updated: November 25, 2013
Last verified: November 2013

March 28, 2012
November 25, 2013
May 2012
October 2013   (final data collection date for primary outcome measure)
Change from baseline in MADRS total score after 8 weeks of treatment in patients with Major Depressive Disorder (MDD) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01571453 on ClinicalTrials.gov Archive Site
  • Change in CGI-S score from baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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).
  • Change in CGI-I score from baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.
  • Change in HAM-A total score from baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.
  • MADRS response at Week 8 (response defined as a ≥50% decrease in the MADRS total score from baseline) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Remission at Week 8 (remission defined as a MADRS total score ≤10) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Safety and tolerability of Vortioxetine [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: Yes ]
    Adverse event monitoring
  • Change in CGI-S score from baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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).
  • Change in CGI-I score from baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.
  • Change in HAM-A total score from baseline to Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.
  • MADRS response at Week 8 (response defined as a ≥50% decrease in the MADRS total score from baseline) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Remission at Week 8 (remission defined as a MADRS total score ≤10) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Safety and tolerability of Lu AA21004 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: Yes ]
    Adverse event monitoring
Not Provided
Not Provided
 
Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Vortioxetine (Lu AA21004)
    10 mg/day
    Other Name: Brintellix
  • Drug: Venlafaxine extended release
    150 mg/day
    Other Name: Efexor® XL
  • Experimental: Vortioxetine (Lu AA21004)
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Active Comparator: Venlafaxine extended release
    Intervention: Drug: Venlafaxine extended release
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
437
Not Provided
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01571453
13926A
No
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP