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Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00839423
First received: February 6, 2009
Last updated: April 22, 2014
Last verified: April 2014

February 6, 2009
April 22, 2014
August 2006
August 2007   (final data collection date for primary outcome measure)
Change From Baseline in MADRS Total Score After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
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.
To evaluate the efficacy of Lu AA21004 versus placebo assessed by change from baseline in MADRS total score after 6 weeks of treatment and evaluate safety by adverse events, laboratory tests, vital signs, ECG, weight and physical examination [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00839423 on ClinicalTrials.gov Archive Site
  • Change From Baseline in MADRS Total Score After 1 Week of Treatment [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.
  • Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in CGI-S Score After 6 Weeks of Treatment [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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.
  • Change in Clinical Status Using CGI-I Score at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.
  • Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of Lu AA21004 compared to placebo during the course of treatment; Efficacy of Lu AA21004 after 1 week; Response and remission rates assessed by MADRS criteria; Effect of Lu AA21004 on Health Related Quality of Life [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder

The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Placebo
    capsules, daily, orally
  • Drug: Vortioxetine (Lu AA21004)
    encapsulated tablets, daily, orally
    Other Name: Brintellix
  • Drug: Venlafaxine XL
    capsules, daily, orally
    Other Name: Effexor®
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Vortioxetine (Lu AA21004) 5 mg
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Experimental: Vortioxetine (Lu AA21004) 10 mg
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Venlafaxine XL 225 mg
    Active Reference
    Intervention: Drug: Venlafaxine XL
Alvarez E, Perez V, Dragheim M, Loft H, Artigas F. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012 Jun;15(5):589-600. doi: 10.1017/S1461145711001027. Epub 2011 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
426
September 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
  • Current MDE duration of at least 3 months and less than 12 months
  • The patient has a MADRS total score >=30

Exclusion Criteria:

  • Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
  • Any substance disorder within the previous 6 months
  • Female patients of childbearing potential who are not using effective contraception
  • Use of any psychoactive medication 2 weeks prior to screening and during the study

Other protocol-defined inclusion and exclusion criteria may apply.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00839423
11492A, 2006-001515-29
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
April 2014

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