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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 [2605 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 [10597 Associated PubMed Articles listed on BioPortfolio]

Effects of the antidepressant medication duloxetine on brain metabolites in persistent depressive disorder: A randomized, controlled trial.

To assess whether patients with Persistent Depressive Disorder (PDD) have abnormal levels of N-acetyl-aspartate (NAA) and whether those levels normalize following treatment with the antidepressant med...

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...

Bidirectional Association between First-Episode Panic Disorder and Major Depressive Disorder in a Nationwide General Population Survey in Korea.

Panic disorder (PD) and major depressive disorder (MDD) can occur concurrently, despite different clinical manifestations. Because MDD and PD patients tend to have more complicated conditions, underst...

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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