Dose-finding Study With Lu AA24530 in Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599911
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Lu AA24530 Drug: Duloxetine Drug: Placebo Phase 2

Detailed Description:
According to the World Health Organisation, Major Depressive Disorder is the leading cause of disability and the 4th leading contributor to the global burden of disease. There are unmet medical needs in the treatment of depressive disorders in terms of insufficient effectiveness and unpleasant side-effects of current therapies. The overall prognosis of the disorder is positive for the majority of patients, but as many as 30% of patients will develop a chronic and treatment-resistant depression. In the study, patients with depression are treated for 6 weeks. Assessments of efficacy and safety are taking place every week for the first 4 weeks and again after 6 weeks of treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 652 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder
Study Start Date : October 2007
Primary Completion Date : March 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Duloxetine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lu AA24530: 5 mg Drug: Lu AA24530
per oral, once daily for 6 weeks
Experimental: Lu AA24530: 10 mg Drug: Lu AA24530
per oral, once daily for 6 weeks
Experimental: Lu AA24530: 20 mg Drug: Lu AA24530
per oral, once daily for 6 weeks
Active Comparator: Duloxetine: 60 mg Drug: Duloxetine
per oral, once daily for 6 weeks
Placebo Comparator: Placebo Drug: Placebo
per oral, once daily for 6 weeks

Primary Outcome Measures :
  1. The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Response rate, remission rate, and safety [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Major Depressive Episode that has lasted at least 3 months
  • Moderate to severe depression

Exclusion Criteria:

  • Any current psychiatric disorder established as the principal diagnosis other than MDD as defined in the DSM-IV-TR and as assessed with the Mini-International Neuropsychiatric Interview (MINI)
  • 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
  • Major Depressive Episode that has been unresponsive to two adequate courses of antidepressant treatment, each of at least 6 weeks duration
  • Electroconvulsive therapy within 6 months prior to Baseline
  • Ongoing formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study
  • Clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
  • The patient is pregnant or breast-feeding

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 identifier (NCT number): NCT00599911

  Show 72 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Study Director: Email contact via H. Lundbeck A/S

Study Data/Documents: EMA EudraCT Results  This link exits the site
Identifier: 2007-001071-11

Responsible Party: H. Lundbeck A/S Identifier: NCT00599911     History of Changes
Other Study ID Numbers: 11918A
2007-001071-11 ( EudraCT Number )
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by H. Lundbeck A/S:
Drug therapy
Depressive disorder
Antidepressive agents
Depressive symptoms
Affective disorders
Randomized controlled trial
Active reference
Multicenter study

Additional relevant MeSH terms:
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