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Sponsored by: |
H. Lundbeck A/S |
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Information provided by: | H. Lundbeck A/S |
ClinicalTrials.gov Identifier: | NCT00766870 |
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 |
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Major Depressive Disorder |
Drug: Lu AA34893 Drug: Venlafaxine extended release Drug: Placebo |
Phase II |
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 |
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 |
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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
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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
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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
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4 |
Drug: Venlafaxine extended release
Per oral, once daily, during 8 weeks, followed by a two-week tapering period
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5: Placebo Comparator |
Drug: Placebo
Per oral doses, twice daily as capsules during 10 weeks
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
In- and out-patients with moderate to severe Major Depressive Disorder
Inclusion Criteria:
Exclusion Criteria:
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 History of Changes |
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 |
Efficacy Safety Depression Interventional |
Placebo Short-term Major Depressive Disorder Major Depressive Episode |
Neurotransmitter Agents Depression Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors Serotonin |
Behavioral Symptoms Mental Disorders Venlafaxine Mood Disorders Antidepressive Agents, Second-Generation Antidepressive Agents |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors Pharmacologic Actions |
Behavioral Symptoms Serotonin Agents Pathologic Processes Mental Disorders Therapeutic Uses Venlafaxine Mood Disorders Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |