Dose-finding Study With Lu AA24530 in Major Depressive Disorder - Full Text View

Purpose

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	Intervention	Phase
Major Depressive Disorder	Drug: Lu AA24530 Drug: Duloxetine Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants 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:

The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate, remission rate, and safety [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	652
Study Start Date:	October 2007
Study Completion Date:	April 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599911

Show 72 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
ClinicalTrials.gov Identifier:	NCT00599911 History of Changes
Other Study ID Numbers:	11918A, 2007-001071-11
Study First Received:	December 28, 2007
Last Updated:	September 24, 2010
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency France: Ministry of Health India: Ministry of Health Lithuania: State Medicine Control Agency - Ministry of Health Malaysia: Ministry of Health Norway: Norwegian Medicines Agency Philippines: Bureau of Food and Drugs Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices South Korea: Korea Food and Drug Administration (KFDA) Sweden: Medical Products Agency Ukraine: Ministry of Health

Keywords provided by H. Lundbeck A/S:

Drug therapy
Depressive disorder
Antidepressive agents
Depressive symptoms
Affective disorders

Randomized controlled trial
Placebo-controlled
Double-blind
Active reference
Multicenter study

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Duloxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on June 13, 2013