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The purpose of the study is to evaluate the efficacy and the safety of two fixed doses of Lu AA21004 in the treatment of Major Depressive Disorder.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Major Depressive Disorder
Lu AA21004, Lu AA21004, Duloxetine, Placebo
H. Lundbeck A/S
Published on BioPortfolio: 2014-08-27T03:13:02-0400
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 trea...
The purpose of this study is to determine the efficacy and safety of Lu AA21004, once daily (QD), in adults with major depressive disorder.
The purpose of this study is to determine the effectiveness and safety of Lu AA21004, once daily (QD), in patients with Major Depressive Disorder.
The purpose of this study is to evaluate the efficacy, safety and tolerability of Lu AA21004, once daily (QD), compared with placebo in adults with major depressive disorder.
The purpose of the study is to evaluate the efficacy and the tolerability of two fixed doses of Lu AA21004 in the acute treatment of Major Depressive Disorder.
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A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
Marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation.
A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
Inability to experience pleasure due to impairment or dysfunction of normal psychological and neurobiological mechanisms. It is a symptom of many PSYCHOTIC DISORDERS (e.g., DEPRESSIVE DISORDER, MAJOR; and SCHIZOPHRENIA).
An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent.
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Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...