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A Study to Asses the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

2014-08-27 03:12:36 | BioPortfolio

Summary

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken for 52 weeks with another antidepressant medicine.

Study Design

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

Conditions

Major Depressive Disorder

Intervention

TC-5214, Placebo

Location

Research Site
Birmingham
Alabama
United States

Status

Recruiting

Source

AstraZeneca

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:36-0400

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A Study to Asses the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken tog...

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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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