A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
1 other identifier
interventional
295
10 countries
66
Brief Summary
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Sep 2010
Shorter than P25 for phase_3 major-depressive-disorder
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
November 20, 2012
CompletedApril 11, 2014
March 1, 2014
1 year
August 5, 2010
June 26, 2012
March 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Randomization (Week 8) to end of treatment (Week 16)
Secondary Outcomes (20)
Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)
Randomization (Week 8) to end of treatment (Week 16)
Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)
Week 16
Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)
Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16
Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)
Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16
Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)
Week 12, Week 14, Week 16
- +15 more secondary outcomes
Study Arms (2)
TC-5214
EXPERIMENTALSelective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
Placebo
PLACEBO COMPARATORSelective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Interventions
Eligibility Criteria
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.
- Out-patient 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.
- History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Targacept Inc.collaborator
Study Sites (66)
Research Site
Brno, Czechia
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Kutná Hora, Czechia
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Litoměřice, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Praha 10 - Strasnice, Czechia
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Tartu, Estonia, Estonia
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Dublin, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Võru, Estonia
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Dublin, Finland
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Espoo, Finland
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Helsinki, Finland
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Kuopio, Finland
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Mikkeli, Finland
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Oulu, Finland
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Tampere, Finland
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Toulon, La Seyne Sur Mer, France
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Douai, France
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Dublin, France
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Élancourt, France
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Jarnac, France
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La Seyne-sur-Mer, France
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Nîmes, France
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Rennes, France
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Toulon, France
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Villejuif, France
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Mainz, Rhineland-Palatinate, Germany
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Berlin, Germany
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Bochum, Germany
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Dublin, Germany
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Siegen, Germany
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Dublin, Hungary
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Dublin, Latvia
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Jelgava, Latvia
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Liepāja, Latvia
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Riga, Latvia
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Sigulda, Latvia
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Strenči, Latvia
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Ziegzdrai, Kaunas County, Lithuania
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Kaunas, Lithuania, Lithuania
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Vilnius, Lithuania, Lithuania
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Dublin, Lithuania
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Palanga, Lithuania
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Šilutė, Lithuania
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Vilnius, Lithuania
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Gdynia, Poland, Poland
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Leszno, Poland, Poland
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Bełchatów, Poland
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Bialystok, Poland
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Bydgoszczy, Poland
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Dublin, Poland
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Gdansk, Poland
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Lublin, Poland
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Sosnowiec, Poland
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Torun, Poland
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Toru, Poland
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Żuromin, Poland
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Dublin, Sweden
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Gothenburg, Sweden
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Halmstad, Sweden
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Lund, Sweden
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Malmo, Sweden
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Solna, Sweden
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Stockholm, Sweden
Related Publications (1)
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.
PMID: 24507016DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Hans A. Eriksson, MD, Ph.D, MBA
AstraZeneca R&D
- PRINCIPAL INVESTIGATOR
D. Naber, Professor Dr.
University Hospital Hamburg
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2010
First Posted
August 12, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
April 11, 2014
Results First Posted
November 20, 2012
Record last verified: 2014-03