A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
NCT ID: NCT01152554
Last Updated: 2014-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
813 participants
INTERVENTIONAL
2010-06-30
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SSRI/Serotonin/SNRI + TC-5214 1-4 mg
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 mg BID
TC-5214
Tablet, oral, twice daily for 52 weeks
SSRI/Serotonin/SNRI + placebo
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + placebo BID
Placebo
Tablet, oral, twice daily for 52 weeks
Interventions
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TC-5214
Tablet, oral, twice daily for 52 weeks
Placebo
Tablet, oral, twice daily for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Targacept Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Hans A. Eriksson, MD, Ph.D, MBA
Role: STUDY_DIRECTOR
AstraZeneca
Andrew . J Cutler, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Clinical Research Center, LLC
Locations
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Research Site
Birmingham, Alabama, United States
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Tuscaloosa, Alabama, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Arcadia, California, United States
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Beverly Hills, California, United States
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Carson, California, United States
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Cerritos, California, United States
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Chino, California, United States
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Costa Mesa, California, United States
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Encino, California, United States
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Escondido, California, United States
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Garden Grove, California, United States
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Irvine, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Pico Rivera, California, United States
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Riverside, California, United States
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Sherman Oaks, California, United States
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Torrance, California, United States
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Upland, California, United States
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Denver, Colorado, United States
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Norwalk, Connecticut, United States
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Norwich, Connecticut, United States
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Bradenton, Florida, United States
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Coral Springs, Florida, United States
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Fort Myers, Florida, United States
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Gainsville, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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North Miami, Florida, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Pinecrest, Florida, United States
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Plantation, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Roswell, Georgia, United States
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Chicago, Illinois, United States
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Hoffman Estates, Illinois, United States
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Joliet, Illinois, United States
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Schaumburg, Illinois, United States
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Skokie, Illinois, United States
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Lafayette, Indiana, United States
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Valparaiso, Indiana, United States
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Prairie Village, Kansas, United States
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Wichita, Kansas, United States
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Florence, Kentucky, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Gaithersburg, Maryland, United States
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Glen Burnie, Maryland, United States
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Rockville, Maryland, United States
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Weymouth, Massachusetts, United States
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Flowood, Mississippi, United States
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Creve Coeur, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Toms River, New Jersey, United States
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Willingboro, New Jersey, United States
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Albuquerque, New Mexico, United States
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Fresh Meadows, New York, United States
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Mount Kisco, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Charlotte, North Carolina, United States
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Wilmington, North Carolina, United States
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Beechwood, Ohio, United States
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Canton, Ohio, United States
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Dayton, Ohio, United States
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Dublin, Ohio, United States
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Mason, Ohio, United States
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Middleburg Heights, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Jenkintown, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Friendswood, Texas, United States
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Irving, Texas, United States
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Lake Jackson, Texas, United States
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San Antonio, Texas, United States
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Woodstock, Vermont, United States
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Seattle, Washington, United States
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South Kirkland, Washington, United States
Research Site
Middleton, Wisconsin, United States
Research Site
San Juan, , Puerto Rico
Countries
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References
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Tummala R, Desai D, Szamosi J, Wilson E, Hosford D, Dunbar G, Eriksson H. Safety and tolerability of dexmecamylamine (TC-5214) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to antidepressant therapy: results of a long-term study. J Clin Psychopharmacol. 2015 Feb;35(1):77-81. doi: 10.1097/JCP.0000000000000269.
Related Links
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CSR-D4130C00007.pdf
D4130C00007/Clinical Study Protocol
Other Identifiers
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D4130C00007
Identifier Type: -
Identifier Source: org_study_id
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