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

2014-08-27 03:13:02 | BioPortfolio

Summary

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.

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 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, Duloxetine, Placebo

Location

FI003
Kuopio
Finland
70110

Status

Recruiting

Source

H. Lundbeck A/S

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:02-0400

Clinical Trials [2090 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 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 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.

Safety and Efficacy of Lu AA21004 in Adults 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.

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 two fixed doses of Lu AA21004 in the acute treatment of Major Depressive Disorder.

PubMed Articles [10452 Associated PubMed Articles listed on BioPortfolio]

A randomized, double-blind comparison of aripiprazole/sertraline combination and placebo/sertraline combination in patients with major depressive disorder.

This study compared the efficacy and safety of aripiprazole/sertraline combination (ASC) and placebo/sertraline combination (PSC) in patients with major depressive disorder (MDD) who showed an inadequ...

Efficacy of Tianeptine 25-50 mg in Elderly Patients With Recurrent Major Depressive Disorder: An 8-Week Placebo- and Escitalopram-Controlled Study.

The present placebo-controlled study evaluated the efficacy and safety of 8 weeks of treatment with tianeptine 25-50 mg/d in elderly patients suffering from major depressive disorder (MDD) according t...

Effect of agomelatine 25-50 mg on functional outcomes in patients with major depressive disorder.

The purpose of this work is to investigate the effect of agomelatine on functioning compared with placebo in patients suffering from Major Depressive Disorder (MDD).

Palmitoylethanolamide as adjunctive therapy in major depressive disorder: A double-blind, randomized and placebo-controlled trial.

Experimental studies provide evidence for antidepressant effects of Palmitoylethanolamide (PEA) in animal models of depression. We aimed to evaluate the efficacy and tolerability of PEA add-on therapy...

A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Fixed-Dose Brexpiprazole 2 mg/d as Adjunctive Treatment of Adults With Major Depressive Disorder.

To assess the efficacy, safety, and tolerability of brexpiprazole as adjunct to antidepressant treatment (ADT) in adults with major depressive disorder (MDD) and inadequate response to ADTs.

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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