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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

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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

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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 766 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 Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder
Study Start Date : February 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


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

Experimental: Vortioxetine: 2.5 mg Drug: Vortioxetine (Lu AA21004)
2.5 mg/day; encapsulated tablets; orally
Other Name: Brintellix

Experimental: Vortioxetine: 5 mg Drug: Vortioxetine (Lu AA21004)
5 mg/day; encapsulated tablets; orally
Other Name: Brintellix

Experimental: Vortioxetine: 10 mg Drug: Vortioxetine (Lu AA21004)
10 mg/day; encapsulated tablets; orally
Other Name: Brintellix

Duloxetine: 60 mg
Active reference
Drug: Duloxetine
60 mg/day; encapsulated capsules; 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. 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.

  2. Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) [ Time Frame: Week 8 ]
  3. 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.

  4. 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 ]
  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. Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10) [ Time Frame: Week 8 ]
  7. 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.

  8. 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.

  9. 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.



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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
Criteria

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.


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): NCT00635219


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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00635219     History of Changes
Other Study ID Numbers: 11984A
EudraCT 2007-001870-95 ( Registry Identifier: EudraCT )
First Posted: March 13, 2008    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
Placebo-controlled
Active reference
Multicenter study
Randomised study
Acute treatment

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Vortioxetine
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
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-HT1 Receptor Antagonists