A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
NCT ID: NCT01153347
Last Updated: 2014-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2409 participants
INTERVENTIONAL
2010-06-30
2012-01-31
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 0.5 mg
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
TC-5214
Tablet, oral, twice daily for 8 weeks
SSRI/Serotonin/SNRI + TC-5214 2 mg
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
TC-5214
Tablet, oral, twice daily for 8 weeks
SSRI/Serotonin/SNRI + TC-5214 4 mg
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
TC-5214
Tablet, oral, twice daily for 8 weeks
SSRI/Serotonin/SNRI + Placebo
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Placebo
Tablet, oral, twice daily for 8 weeks
Interventions
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TC-5214
Tablet, oral, twice daily for 8 weeks
Placebo
Tablet, oral, twice daily for 8 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.
* History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product.
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,PhD, 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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Tucson, Arizona, United States
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Conway, Arkansas, 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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Garden Grove, 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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Oakland, California, United States
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Oceanside, California, United States
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Pico Rivera, California, United States
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Santa Ana, California, United States
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Upland, California, United States
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Denver, Colorado, United States
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Cromwell, Connecticut, United States
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New London, Connecticut, United States
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Norwich, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Fort Myers, Florida, United States
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Fort Walton Beach, Florida, United States
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Gainsville, Florida, United States
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Jacksonville, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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South Miami, 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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Atlanta, Georgia, United States
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Roswell, Georgia, 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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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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Baltimore, Maryland, United States
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Gaithersburg, Maryland, United States
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Boston, Massachusetts, United States
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Weymouth, Massachusetts, United States
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Flowood, Mississippi, United States
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St Louis, Missouri, United States
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North Platte, 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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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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Avon Lake, Ohio, United States
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Beachwood, Ohio, United States
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Beechwood, Ohio, United States
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Cincinnati, Ohio, United States
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Mason, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sellersvillle, Pennsylvania, United States
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Lincoln, Rhode Island, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Murray, Utah, United States
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Bellevue, Washington, United States
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Bothell, Washington, United States
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Seattle, Washington, United States
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South Kirkland, Washington, United States
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Spokane, Washington, United States
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Guntur, Andhra Pradesh, India
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Vijayawada, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Anand, Gujarat, India
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Jūnāgadh, Gujarat, India
Research Site
Rajkot, Gujarat, India
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Vadodara, Gujarat, India
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Bangalore, Karnataka, India
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Aurangabad, Maharashtra, India
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Pune, Maharashtra, India
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Nashik, Mahara, India
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Durham, NC, India
Research Site
Chennai, Tamil Nadu, India
Research Site
Madurai, Tamil Nadu, India
Research Site
Lucknow, Uttar Pradesh, India
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Varanasi, Uttar Prad, India
Research Site
Kanpur, , India
Research Site
Karnataka, , India
Research Site
Mysore, , India
Research Site
San Juan, , Puerto Rico
Countries
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References
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Moller HJ, Demyttenaere K, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Two Phase III randomised double-blind studies of fixed-dose TC-5214 (dexmecamylamine) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to prior antidepressant therapy. World J Biol Psychiatry. 2015 Oct;16(7):483-501. doi: 10.3109/15622975.2014.989261. Epub 2015 Jan 20.
Related Links
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CSR-D4130C00004.pdf
D4130C00004/Clinical Study Protocol
Other Identifiers
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D4130C00004
Identifier Type: -
Identifier Source: org_study_id
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