A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
NCT ID: NCT01180400
Last Updated: 2014-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
295 participants
INTERVENTIONAL
2010-09-30
2011-09-30
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
D. Naber, Professor Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Hamburg
Locations
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Research Site
Brno, , Czechia
Research Site
Kutná Hora, , Czechia
Research Site
Litoměřice, , Czechia
Research Site
Pilsen, , Czechia
Research Site
Prague, , Czechia
Research Site
Praha 10 - Strasnice, , Czechia
Research Site
Tartu, Estonia, Estonia
Research Site
Dublin, , Estonia
Research Site
Tallinn, , Estonia
Research Site
Tartu, , Estonia
Research Site
Võru, , Estonia
Research Site
Dublin, , Finland
Research Site
Espoo, , Finland
Research Site
Helsinki, , Finland
Research Site
Kuopio, , Finland
Research Site
Mikkeli, , Finland
Research Site
Oulu, , Finland
Research Site
Tampere, , Finland
Research Site
Toulon, La Seyne Sur Mer, France
Research Site
Douai, , France
Research Site
Dublin, , France
Research Site
Élancourt, , France
Research Site
Jarnac, , France
Research Site
La Seyne-sur-Mer, , France
Research Site
Nîmes, , France
Research Site
Rennes, , France
Research Site
Toulon, , France
Research Site
Villejuif, , France
Research Site
Mainz, Rhineland-Palatinate, Germany
Research Site
Berlin, , Germany
Research Site
Bochum, , Germany
Research Site
Dublin, , Germany
Research Site
Siegen, , Germany
Research Site
Dublin, , Hungary
Research Site
Dublin, , Latvia
Research Site
Jelgava, , Latvia
Research Site
Liepāja, , Latvia
Research Site
Riga, , Latvia
Research Site
Sigulda, , Latvia
Research Site
Strenči, , Latvia
Research Site
Ziegzdrai, Kaunas County, Lithuania
Research Site
Kaunas, Lithuania, Lithuania
Research Site
Vilnius, Lithuania, Lithuania
Research Site
Dublin, , Lithuania
Research Site
Palanga, , Lithuania
Research Site
Šilutė, , Lithuania
Research Site
Vilnius, , Lithuania
Research Site
Gdynia, Poland, Poland
Research Site
Leszno, Poland, Poland
Research Site
Bełchatów, , Poland
Research Site
Bialystok, , Poland
Research Site
Bydgoszczy, , Poland
Research Site
Dublin, , Poland
Research Site
Gdansk, , Poland
Research Site
Lublin, , Poland
Research Site
Sosnowiec, , Poland
Research Site
Torun, , Poland
Research Site
Toru, , Poland
Research Site
Żuromin, , Poland
Research Site
Dublin, , Sweden
Research Site
Gothenburg, , Sweden
Research Site
Halmstad, , Sweden
Research Site
Lund, , Sweden
Research Site
Malmo, , Sweden
Research Site
Solna, , Sweden
Research Site
Stockholm, , Sweden
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-D4130C00003.pdf
D4130C00003/Clinical Study Protocol
Other Identifiers
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D4130C00003
Identifier Type: -
Identifier Source: org_study_id
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