A Study to Assess the Long- Term 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, MDD, 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 for 52 weeks with another antidepressant medicine.

Key facts

Study ID

NCT01152554

Run by

AstraZeneca

People needed

813

Starts

2010-06-01

Expected to finish

2012-02-01

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.
• Patients with significant liver, kidney, lung, heart, neurological, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.

Where it is running

• Research Site — Tuscaloosa, Alabama, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Arcadia, California, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Carson, California, United States
• Research Site — Cerritos, California, 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 — Garden Grove, California, United States
• Research Site — Irvine, California, United States
• Research Site — Los Alamitos, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Pico Rivera, California, United States
• Research Site — Riverside, California, United States
• Research Site — Sherman Oaks, California, United States
• Research Site — Torrance, California, United States
• Research Site — Upland, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Norwalk, Connecticut, United States
• Research Site — Norwich, Connecticut, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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