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A Fixed Dose Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder

2014-08-27 04:00:42 | BioPortfolio

Summary

The primary purpose of this study is to assess whether at least one dose of LY2216684 (12 mg or 18 mg once daily) is superior to placebo once daily in the adjunctive treatment of patients with major depressive disorder (MDD) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI), during an 11-week, double-blind, acute adjunctive treatment phase.

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

LY2216684, Placebo

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559)
Irvine
California
United States
92618

Status

Completed

Source

Eli Lilly and Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:42-0400

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A Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder

The primary purpose is to study the efficacy, safety, and tolerability of LY2216684 as an adjunctive treatment for patients with major depressive disorder (MDD), who were identified as par...

A Study for Patients With Major Depression

This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in treating adults with major depressive disorder.

A Study in Adult Patients With Major Depressive Disorder

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A Safety Study in Patients With Major Depressive Disorder

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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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