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Efficacy and Safety of Lu AA21004 in the Treatment of Subjects With Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00672620
First received: May 2, 2008
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to determine the efficacy and safety of Lu AA21004, once daily (QD), in adults with major depressive disorder.


Condition Intervention Phase
Major Depressive Disorder
 Drug: Lu AA21004
Drug: Duloxetine
Drug: Placebo
 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 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • The least squares mean change from Baseline in the 24-item Hamilton Depression Scale total score after 8 weeks of treatment. [ Time Frame: Baseline and Weeks 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The least squares mean change from Baseline in the 24-item Hamilton Depression Scale total score at each week assessed. [ Time Frame: Baseline and Weeks 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]
  • Response rates at each week assessed, with response defined as a ≥ 50% decrease in the 24-item Hamilton Depression Scale total score from Baseline. [ Time Frame: Baseline and Weeks 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]
  • Sustained response from Week 1, with sustained response defined as a ≥ 20% decrease from Baseline in the 24-item Hamilton Depression Scale total score obtained at Week 1 and through week 6 and ≥ 50% decrease from baseline. [ Time Frame: Baseline and Weeks 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]
  • Remission rates at Week 8, with remission defined as a Montgomery Åsberg Depression Rating Scale total score ≤10. [ Time Frame: Week 8. ] [ Designated as safety issue: No ]
  • The least squares mean change from Baseline in the Montgomery Åsberg Depression Rating Scale total score [ Time Frame: Baseline and Weeks 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]
  • The least squares mean change from Baseline in the Clinical Global Impression Scale-Global Improvement Scale [ Time Frame: Baseline and Weeks 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]
  • The least squares mean change from Baseline in the Montgomery-Åsberg Depression Rating Scale Self-assessment. [ Time Frame: Baseline and Weeks 1, 4 and 8. ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale. [ Time Frame: Weeks 1, 2, 6 and 8. ] [ Designated as safety issue: No ]
  • Healthcare resource utilization as assessed by the Health Economic Assessment Questionnaire. [ Time Frame: Week 8. ] [ Designated as safety issue: No ]
  • The least squares mean change from Baseline in the Hamilton Anxiety Scale [ Time Frame: Baseline and Weeks 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]
  • The least squares mean change from Baseline in the Clinical Global Impression Scale-Severity of Illness Scale [ Time Frame: Baseline and Weeks 1, 2, 4, 6 and 8. ] [ Designated as safety issue: No ]

Enrollment: 611
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AA21004 2.5 mg QD Drug: Lu AA21004
Lu AA21004 2.5 mg, capsules, orally, once daily for up to 8 weeks.
Experimental: Lu AA21004 5 mg QD Drug: Lu AA21004
Lu AA21004 5 mg, capsules, orally, once daily for up to 8 weeks.
Active Comparator: Duloxetine 60 mg QD Drug: Duloxetine

Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks*

*taper down to 30 mg capsule, orally, once daily for 1 week after the treatment period.

Other Name: Cymbalta®
Placebo Comparator: Placebo QD Drug: Placebo
Placebo-matching capsules, orally, once daily for up to 8 weeks.

Detailed Description:

Depression has been recognized as a chronic illness that imposes a significant burden on individuals, families and society. Major depressive disorder is among the most important cause of disability worldwide, in both developing and developed countries. Major depressive disorder is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. Major depressive disorder is characterized by the presence of 1 or more major depressive episodes that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. Studies suggest that at least 70% of depressed patients also report somatic symptoms such as pain, shortness of breath, fatigue, or nausea. A number of patients may present with somatic symptoms as the main complaint rather than depressed mood. Depression is recurrent in 75% to 80% of patients, becomes chronic (i.e., lasting 2 years or longer) in 15% to 20% of depressed patients, and can lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. Furthermore, depression may lead to suicide and the mortality due to suicide is approximately 15% among patients treated by psychiatrists. Major depressive disorder imposes a socioeconomic burden comparable to chronic medical illnesses in terms of healthcare utilization, decreased productivity, and dysfunctional family life, and is associated with an increased consumption of general medical, psychiatric and emergency services.

Lu AA21004 is a compound under development by Takeda Pharmaceutical Company Limited and H. Lundbeck A/S with clinical development for the treatment of major depressive disorder.

  Eligibility

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

Inclusion Criteria:

  • The subject suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
  • The reported duration of the current major depressive episode is at least 3 months.

Exclusion Criteria:

  • The subject has 1 or more the following:

    • Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
    • Current or past 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.
    • Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
    • Presence or history of a clinically significant neurological disorder (including epilepsy).
    • Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
    • Any Axis II disorder that might compromise the study.
  • The subject has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
  • The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
  • The subject has received electroconvulsive therapy within 6 months prior to Screening.
  • The subject is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672620

  Show 38 Study Locations
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
H. Lundbeck A/S
Investigators
Study Director: Medical Director Takeda Global Research & Development Center, Inc.
  More Information

No publications provided by Takeda Global Research & Development Center, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00672620     History of Changes
Other Study ID Numbers: LuAA21004_304, U1111-1114-3497
Study First Received: May 2, 2008
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
Major Depressive Disorder
Depression
Drug Therapy
Major Depressive Episode

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 May 19, 2013