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Study to Evaluate Safety and Tolerability of FK949E in Elderly Patients With Major Depressive Disorder

2014-08-27 04:00:43 | BioPortfolio

Summary

The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation of quetiapine) in elderly patients with major depressive disorder (MDD).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Major Depressive Disorder Patients

Intervention

FK949E

Location

Kansai
Japan

Status

Completed

Source

Astellas Pharma Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:43-0400

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Medical and Biotech [MESH] Definitions

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)

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.

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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