A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)
NCT ID: NCT01157078
Last Updated: 2014-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
319 participants
INTERVENTIONAL
2010-06-30
2011-11-30
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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TC-5214
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
TC-5214
Tablet, oral, twice daily for 8 weeks
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.
* Out-patient 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 the investigational product in this patient population
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 R&D
Bernadette D'Souza, MD
Role: PRINCIPAL_INVESTIGATOR
Midwest Clinical Research Center, Ohio
Locations
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Research Site
Tuscaloosa, Alabama, United States
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
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Orlando, Florida, United States
Research Site
Tampa, Florida, United States
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Chicago, Illinois, United States
Research Site
Prairie Village, Kansas, United States
Research Site
Florence, Kentucky, United States
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Shreveport, Louisiana, United States
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St Louis, Missouri, United States
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New York, New York, United States
Research Site
Rochester, New York, United States
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Staten Island, New York, United States
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Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Middleburg Heights, Ohio, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
Research Site
Norristown, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
Research Site
Woodstock, Vermont, United States
Research Site
Seattle, Washington, United States
Research Site
Visakhapatnam, Andh Prad, India
Research Site
Guntur, Andhra Pradesh, India
Research Site
Ahmedabad, Gujarat, India
Research Site
Rajkot, Gujarat, India
Research Site
Mangalore, Karnataka, India
Research Site
Aurangabad, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
Nashik, Mahara, India
Research Site
Jaipur, Rajasthan, India
Research Site
Khātīpura, Rajasthan, India
Research Site
Madurai, Tamil Nadu, India
Research Site
Varanasi, Uttar Prad, India
Research Site
Kanpur, , India
Research Site
Mysore, , India
Countries
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References
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Vieta E, Thase ME, Naber D, D'Souza B, Rancans E, Lepola U, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant. Eur Neuropsychopharmacol. 2014 Apr;24(4):564-74. doi: 10.1016/j.euroneuro.2013.12.008. Epub 2013 Dec 21.
Related Links
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CSR-D4130C00002.pdf
D4130C00002\_Clinical\_Study\_Protocol
Other Identifiers
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D4130C00002
Identifier Type: -
Identifier Source: org_study_id
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