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Efficacy and Safety of Lu AA21004 in Acute Treatment of Major Depressive Disorder

2014-07-24 14:14:24 | BioPortfolio

Summary

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.

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. Lu AA21004 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Major Depressive Disorder

Intervention

Lu AA21004, Lu AA21004, Placebo, Venlafaxine XL

Status

Completed

Source

H. Lundbeck A/S

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:14:24-0400

Clinical Trials [2552 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of Lu AA21004 in Acute Treatment of Major Depressive Disorder

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...

Efficacy and Safety of Lu AA21004 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.

Efficacy and Safety of Lu AA21004 in Acute Treatment of Major Depressive Disorder

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.

Efficacy and Safety of Lu AA21004 in the Treatment of Subjects With Major Depressive Disorder

The purpose of this study is to determine the efficacy and safety of Lu AA21004, once daily (QD), in adults with major depressive disorder.

Efficacy and Safety Study of Lu AA21004 in Adults With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy of Lu AA21004, once daily (QD), compared with placebo in adults with major depressive disorder.

PubMed Articles [10608 Associated PubMed Articles listed on BioPortfolio]

No association between CYP2C19 genetic polymorphism with treatment remission to antidepressant venlafaxine in Han Chinese population.

Major depressive disorder (MDD) is a global mental health problem. As a serotonin-noradrenaline reuptake inhibitor (SNRI), the antidepressant venlafaxine is used to alleviate MDD clinically. Recent re...

Pharmacological and non-pharmacological treatments for major depressive disorder in adults: A systematic review and network meta-analysis.

Depression has brought huge disease burden to the world. This systematic review aimed to compare the efficacy and safety of pharmacological and non-pharmacological treatments for major depressive diso...

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Vortioxetine in Japanese Patients With Major Depressive Disorder.

The burden of major depressive disorder (MDD) in Japan is high. This study aimed to evaluate the efficacy and safety of the multimodal antidepressant vortioxetine in Japanese patients with MDD.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY).

Pimavanserin is a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist. This phase 2 study examined the efficacy and safety of pimavanserin as adjunctive therapy in patients with major depre...

Brexpiprazole as adjunctive treatment for major depressive disorder following treatment failure with at least one antidepressant in the current episode: a systematic review and meta-analysis.

This systematic review and meta-analysis included double-blind, randomized, placebo-controlled trials of brexpiprazole adjunctive treatment (0.5-3 mg/d) for major depressive disorder (MDD) where antid...

Medical and Biotech [MESH] Definitions

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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