Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00635219
Recruitment Status : Completed
First Posted : March 13, 2008
Results First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE March 3, 2008
First Posted Date  ICMJE March 13, 2008
Results First Submitted Date October 28, 2013
Results First Posted Date February 11, 2014
Last Update Posted Date February 11, 2014
Study Start Date  ICMJE February 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
Change From Baseline in MADRS Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
To evaluate the efficacy of three fixed doses of Lu AA21004 versus placebo after 8 weeks of treatment assessed by change from baseline in MADRS total score [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT00635219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
  • Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ]
    The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
  • Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) [ Time Frame: Week 8 ]
  • Change in Clinical Status Using CGI-I Score at Week 8 [ Time Frame: Week 8 ]
    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.
  • Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score >=20 [ Time Frame: Baseline and Week 8 ]
  • Change From Baseline in SDS Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ]
    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.
  • Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Week 8 ]
  • Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ]
    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 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ]
    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 From Baseline in ASEX Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ]
    The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated 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. A negative change indicates a lower sexual dysfunction.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
To evaluate the safety and tolerability of Lu AA21004 compared to placebo during the course of treatment; Response and remission rates assessed by MADRS criteria; Effect of Lu AA21004 on Health Related Quality of Life and disability [ Time Frame: 8 weeks ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomised Placebo-controlled Duloxetine-referenced Efficacy and Safety Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder
Official Title  ICMJE A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder
Brief Summary The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Vortioxetine in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder (MDD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Placebo
    capsules; daily; orally
  • Drug: Vortioxetine (Lu AA21004)
    2.5 mg/day; encapsulated tablets; orally
    Other Name: Brintellix
  • Drug: Vortioxetine (Lu AA21004)
    5 mg/day; encapsulated tablets; orally
    Other Name: Brintellix
  • Drug: Vortioxetine (Lu AA21004)
    10 mg/day; encapsulated tablets; orally
    Other Name: Brintellix
  • Drug: Duloxetine
    60 mg/day; encapsulated capsules; orally
    Other Name: Cymbalta®
Study Arms
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Vortioxetine: 2.5 mg
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Experimental: Vortioxetine: 5 mg
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Experimental: Vortioxetine: 10 mg
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Duloxetine: 60 mg
    Active reference
    Intervention: Drug: Duloxetine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2013)
766
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2008)
660
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
  • Moderate to severe depression
  • Current MDE duration of at least 3 months

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Bulgaria,   Canada,   Czech Republic,   Estonia,   France,   India,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Philippines,   Romania,   Slovakia,   Spain,   Taiwan,   Turkey,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT00635219
Other Study ID Numbers  ICMJE 11984A
EudraCT 2007-001870-95 ( Registry Identifier: EudraCT )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date December 2013

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