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Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder

2016-09-29 23:08:21 | BioPortfolio

Summary

To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and vortioxetine 10 mg/day oral dose regimen versus vortioxetine 10 mg/day oral dose regimen on depressive symptoms

To evaluate the early onset of efficacy of vortioxetine 17 mg IV and vortioxetine 10 mg/day oral dose regimen versus vortioxetine 10 mg/day oral dose regimen on

- global clinical impression

- anxiety symptoms

To determine population pharmacokinetic parameters of vortioxetine

Study Design

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

Conditions

Depressive Disorder, Major

Intervention

Vortioxetine (IV), Placebo (IV), Vortioxetine (tablet)

Location

FI1040
Helsinki
Finland

Status

Recruiting

Source

H. Lundbeck A/S

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-29T23:08:21-0400

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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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