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A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

2014-08-27 04:00:30 | BioPortfolio

Summary

This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.

Description

The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using other scales and assessments.

Study Design

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

Conditions

Major Depressive Disorder

Intervention

ALKS 5461, Placebo

Location

Alkermes Investigational Site
Tucson
Arizona
United States
85712

Status

Completed

Source

Alkermes

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:30-0400

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A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)

This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.

A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

This study will evaluate the efficacy and safety of ALKS 5461.

A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.

A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users

This study will evaluate the abuse potential of ALKS 5461.

A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers

This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.

PubMed Articles [10665 Associated PubMed Articles listed on BioPortfolio]

Neurophysiological Changes Associated with Antidepressant Response to Ketamine Not Observed in a Negative Trial of Scopolamine in Major Depressive Disorder.

This randomized, placebo-controlled, crossover trial examined the antidepressant efficacy of the muscarinic antagonist scopolamine in major depressive disorder subjects with more severe and refractory...

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).

Desvenlafaxine vs. placebo in the treatment of persistent depressive disorder.

Pharmacotherapy of non-major persistent depressive disorder (PDD) is little studied. We report a study of the serotonin-norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (DVLX) for PDD.

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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