Efficacy and Safety of Lu AA34893 in Patients With Major Depressive Disorder - Full Text View

Sponsored by:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00766870

Purpose

The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Lu AA34893 Drug: Venlafaxine extended release Drug: Placebo	Phase II

MedlinePlus related topics: Depression

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, and Active-Referenced Study Evaluating the Efficacy and Safety of Three Fixed Dose Regimens of Lu AA34893 in the Treatment of Major Depressive Disorder

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

Primary Outcome Measures:

Depressive symptoms as measured by the change from baseline in MADRS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lu AA34893 Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
2: Experimental	Drug: Lu AA34893 Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
3: Experimental	Drug: Lu AA34893 Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
4	Drug: Venlafaxine extended release Per oral, once daily, during 8 weeks, followed by a two-week tapering period
5: Placebo Comparator	Drug: Placebo Per oral doses, twice daily as capsules during 10 weeks

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 AA34893 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

In- and out-patients with moderate to severe Major Depressive Disorder

Inclusion Criteria:

Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (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
Females of childbearing potential and not using adequate contraception
Use of any psychoactive medication within 2 weeks before randomisation and during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766870

Locations

Canada, Ontario
CA009
Mississauga, Ontario, Canada, ON L5M 4N4

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

Responsible Party:	H. Lundbeck A/S ( H. Lundbeck A/S )
Study ID Numbers:	12279A, EudraCT: 2007-007025-51
Study First Received:	October 3, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00766870
Health Authority:	Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; South Africa: Medicines Control Council

Keywords provided by H. Lundbeck A/S:

Efficacy
Safety
Depression
Interventional

Placebo
Short-term
Major Depressive Disorder
Major Depressive Episode

Study placed in the following topic categories:

Depression
Mental Disorders
Venlafaxine
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009