A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.

Key facts

Study ID

NCT01288079

Run by

AstraZeneca

People needed

145

Starts

2011-02-01

Expected to finish

2012-08-01

Last updated by the study team

2012-11-20

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.
• Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
• 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 any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
• History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
• Pregnancy or lactation.

Where it is running

• Research Site — Chino, California, United States
• Research Site — Garden Grove, California, United States
• Research Site — San Diego, California, United States
• Research Site — Torrance, California, United States
• Research Site — Bradenton, Florida, United States
• Research Site — Coral Springs, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — North Miami, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Joliet, Illinois, United States
• Research Site — Prairie Village, Kansas, United States
• Research Site — Flowood, Mississippi, United States
• Research Site — New York, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Dayton, Ohio, United States
• Research Site — Mason, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Allentown, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Seattle, Washington, United States
• Research Site — Madison, Wisconsin, United States
• Research Site — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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