Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 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:
NCT01140906
First received: June 9, 2010
Last updated: December 23, 2013
Last verified: December 2013

June 9, 2010
December 23, 2013
May 2010
September 2011   (final data collection date for primary outcome measure)
Change From Baseline in MADRS Total Score After 8 Weeks of Treatment. [ Time Frame: Baseline and Week 8 ] [ 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 two fixed doses of Lu AA21004 (15 or 20 mg/day) versus placebo as assessed by the change from baseline in MADRS total score after 8 weeks of treatment in adult patients with moderate to severe MDD. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01140906 on ClinicalTrials.gov Archive Site
  • Proportion of Responders 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 ]
  • Change in Clinical Status Using CGI-I Score at Week 8 [ Time Frame: Week 8 ] [ 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.
  • Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline in SDS Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in ASEX Total Score After 8 Weeks of Treatment [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: Yes ]
    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.
  • Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine [ Time Frame: Change from Week 8 in DESS total score analyzed at Week 10 ] [ Designated as safety issue: Yes ]
    The Discontinuation-Emergent Signs and Symptoms Scale (DESS) was designed to evaluate possible effects of discontinuation of antidepressant therapy. It is a clinician-rated instrument that queries for signs and symptoms on a 43-item checklist (for example, agitation, insomnia, fatigue, and dizziness) to assess whether the item (event) is discontinuation-emergent. A new or worsened event reported after discontinuation of therapy scores 1 point on the checklist, and the DESS total score is the sum of all positive scores on the checklist. A higher score indicates more symptoms.
  • To compare the effect of Lu AA21004 to that of placebo at Week 8 on patients who respond (response defined as a >=50% decrease in the MADRS total score from baseline) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To compare the effect of Lu AA21004 to that of placebo at Week 8 on global improvement as assessed by CGI-I [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To compare the effect of Lu AA21004 to that of placebo at Week 8 on depressive symptoms in patients with a high baseline level of anxiety (defined by HAM-A), as assessed by MADRS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To compare the effect of Lu AA21004 to that of placebo at Week 8 on patients who are in remission (remission defined as a MADRS total score <=10) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To compare the effect of Lu AA21004 to that of placebo at Week 8 on disability as assessed by SDS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To evaluate the effect of Lu AA21004 on sexual function as assessed by ASEX versus placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the safety and tolerability of Lu AA21004 (15 or 20 mg/day) versus placebo during treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the potential discontinuation symptoms after abrupt discontinuation of treatment with Lu AA21004 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Lu AA21004 (15 and 20 mg/Day) in the Acute Treatment of Adult Patients With Major Depressive Disorder

The purpose of the study is to evaluate the efficacy, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder.

Not Provided
Interventional
Phase 3
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: Duloxetine
    encapsulated capsules, daily, orally
    Other Name: Cymbalta®
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Vortioxetine: 15 mg
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Experimental: Vortioxetine: 20 mg
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Duloxetine: 60 mg
    Active Reference
    Intervention: Drug: Duloxetine
Boulenger JP, Loft H, Olsen CK. Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder. Int Clin Psychopharmacol. 2014 May;29(3):138-49. doi: 10.1097/YIC.0000000000000018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
607
Not Provided
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x)
  • The patient has a MADRS total score >=26
  • The patient has a CGI-S score >=4
  • The patient has had the current episode of MDE for >3 months

Exclusion Criteria:

  • Any current anxiety psychiatric disorder as defined in the DSM-IV TR
  • Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV TR
  • Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR
  • Use of any psychoactive medication 2 weeks prior to screening and during the study
  • The patient is at significant risk of suicide or has a score >=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit

Other protocol-defined inclusion and exclusion criteria may apply.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01140906
13267A, 2009-017523-26
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
December 2013

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