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

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder, Depression

In brief

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 together with another antidepressant.

Key facts

Study ID

NCT01153347

Run by

AstraZeneca

People needed

2409

Starts

2010-06-01

Expected to finish

2012-01-01

Last updated by the study team

2014-04-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent before initiation of any study-related procedures.
• The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
• Outpatient status at enrollment and randomization.

You may not qualify if…

• Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
• Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
• History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product.

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Conway, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Arcadia, California, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Garden Grove, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Oakland, California, United States
• Research Site — Oceanside, California, United States
• Research Site — Pico Rivera, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Upland, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Cromwell, Connecticut, United States
• Research Site — New London, Connecticut, United States
• Research Site — Norwich, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Bradenton, Florida, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Fort Walton Beach, Florida, United States
• Research Site — Gainsville, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — North Miami, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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