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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

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ClinicalTrials.gov Identifier: NCT01140906
Recruitment Status : Completed
First Posted : June 10, 2010
Results First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Placebo Drug: Vortioxetine (Lu AA21004) Drug: Duloxetine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 607 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2010
Actual Primary Completion Date : September 2011

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
capsules, daily, orally

Experimental: Vortioxetine: 15 mg Drug: Vortioxetine (Lu AA21004)
encapsulated tablets, daily, orally
Other Name: Brintellix

Experimental: Vortioxetine: 20 mg Drug: Vortioxetine (Lu AA21004)
encapsulated tablets, daily, orally
Other Name: Brintellix

Duloxetine: 60 mg
Active Reference
Drug: Duloxetine
encapsulated capsules, daily, orally
Other Name: Cymbalta®

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) [ Time Frame: Week 8 ]
  2. 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.

  3. 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 ]
  4. Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Week 8 ]
  5. 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.

  6. 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.

  7. Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine [ Time Frame: Change from Week 8 in DESS total score analyzed at Week 10 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140906

Sponsors and Collaborators
H. Lundbeck A/S
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01140906    
Other Study ID Numbers: 13267A
2009-017523-26 ( EudraCT Number )
First Posted: June 10, 2010    Key Record Dates
Results First Posted: February 11, 2014
Last Update Posted: February 11, 2014
Last Verified: December 2013
Keywords provided by H. Lundbeck A/S:
Major depressive disorder
Active reference
Multicenter study
Randomised study
Acute treatment
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Serotonin Uptake Inhibitors
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists