SA4503 8-Week Study in Major Depressive Disorder (MDD)
Summary
The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety of SA4503 compared to placebo in subjects with MDD.
Description
Further study details as provided by M's Science Corporation:
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Depressive Disorder, Major
Intervention
placebo, SA4503 Low, SA4503 High
Location
Helsinki
Finland
Status
Completed
Source
M's Science Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00551109
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bipolar Disorder
A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
Trazodone
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)
Depressive Disorder, Major
Marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation.
Depressive Disorder
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.
Depression
Depressive states usually of moderate intensity in contrast with major depression present in neurotic and psychotic disorders.
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