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
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: Placebo
Drug: Vortioxetine (Lu AA21004)
Drug: Duloxetine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 607
Study Start Date: May 2010
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140906

Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided by H. Lundbeck A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01140906     History of Changes
Other Study ID Numbers: 13267A, 2009-017523-26
Study First Received: June 9, 2010
Results First Received: October 28, 2013
Last Updated: December 23, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Norway: Norwegian Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by H. Lundbeck A/S:
Major depressive disorder
Placebo-controlled
Active reference
Multicenter study
Randomised study
Acute treatment

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014