Efficacy and Safety of Lu AA21004 in Acute Treatment of Major Depressive Disorder - Full Text View

Sponsored by:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00635219

Purpose

The purpose of the study is to evaluate the efficacy and the tolerability of three fixed doses of Lu AA21004 in order to establish the appropriate clinical effective dose range in the treatment of Major Depressive Disorder.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Lu AA21004 Drug: Duloxetine Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study, With Active Reference, Evaluating the Efficacy and Safety of Three Doses of Lu AA21004, in Acute Treatment of Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

To evaluate the efficacy of three fixed doses of Lu AA21004 versus placebo after 8 weeks of treatment assessed by change from baseline in MADRS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of Lu AA21004 compared to placebo during the course of treatment; Response and remission rates assessed by MADRS criteria; Effect of Lu AA21004 on Health Related Quality of Life and disability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	776
Study Start Date:	February 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lu AA21004: 2,5 mg: Experimental	Drug: Lu AA21004 per oral; 2,5 mg/day
Lu AA21004: 5 mg: Experimental	Drug: Lu AA21004 per oral, 5 mg/day
Lu AA21004: 10 mg: Experimental	Drug: Lu AA21004 per oral; 10 mg/day
Duloxetine: 60 mg Active reference	Drug: Duloxetine per oral; 60 mg/day
Placebo: Placebo Comparator	Drug: Placebo per oral; daily

Detailed Description:

Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) 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. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA21004 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.

Eligibility

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

Criteria

Inclusion Criteria:

Major Depressive Episode (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635219

Show 79 Study Locations

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

Responsible Party:	H. Lundbeck A/S ( H. Lundbeck A/S )
Study ID Numbers:	11984A, EudraCT 2007-001870-95
Study First Received:	March 3, 2008
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00635219 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; France: Afssaps - French Health Products Safety Agency; Lithuania: State Medicine Control Agency - Ministry of Health; Malaysia: Ministry of Health; Philippines: Bureau of Food and Drugs; South Korea: Korea Food and Drug Administration (KFDA); Spain: Spanish Agency of Medicines; Taiwan: National Bureau of Controlled Drugs; Turkey: Ministry of Health; Ukraine: Ministry of Health

Keywords provided by H. Lundbeck A/S:

Major depressive disorder
Placebo-controlled
Active reference

Multicenter study
Randomised study
Acute treatment

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors

Duloxetine
Serotonin
Behavioral Symptoms
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder

Serotonin Uptake Inhibitors
Pharmacologic Actions
Duloxetine
Behavioral Symptoms
Serotonin Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 10, 2009