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

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

NCT01157078

Run by

AstraZeneca

People needed

319

Starts

2010-06-01

Expected to finish

2011-11-01

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.
• Out-patient 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 the investigational product in this patient population

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Chino, California, United States
• Research Site — Costa Mesa, California, United States
• Research Site — Encino, California, United States
• Research Site — Escondido, California, United States
• Research Site — Los Alamitos, California, United States
• Research Site — Oceanside, California, United States
• Research Site — Pico Rivera, California, United States
• Research Site — San Diego, California, United States
• Research Site — Torrance, California, United States
• Research Site — Hamden, Connecticut, United States
• Research Site — Coral Springs, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Orange City, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Prairie Village, Kansas, United States
• Research Site — Florence, Kentucky, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — St Louis, Missouri, United States
• Research Site — New York, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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