Clinical trial NCT01152554: A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III, Long-Term Safety and Tolerability Study of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
MDD
Depression
Keywords: Major Depressive Disorder
MDD
Depression
Safety
add-on therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Targacept Inc.
First posted: 2010-06-29
Enrollment: 813
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 for 52 weeks with another antidepressant medicine.


Eligibility criteria: Inclusion Criteria:

* 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.
* Outpatient status at enrollment and randomization.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Frequency of Patients Experiencing at Least One Adverse Event (AE)
timeFrame: Randomization (Week 0) to end of the follow-up period (Week 54)
measure: Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
timeFrame: Randomization (Week 0) to end of the follow-up period (Week 54)
measure: Frequency of Patients Experiencing Serious Adverse Events (SAEs)
timeFrame: Randomization (Week 0) to end of the follow-up period (Week 54)
Secondary outcomes:
measure: Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24
timeFrame: Week 12 to Week 24
measure: Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52
timeFrame: Week 12 to Week 52
measure: Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)
timeFrame: Randomization (Week 0) to end of treatment (Week 52)
measure: Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score
timeFrame: Randomization (Week 0) to end of treatment (Week 52)
measure: Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score
timeFrame: Randomization (Week 0) to end of treatment (Week 52)
measure: Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)
timeFrame: Randomization (Week 0) to end of treatment (Week 52)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
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state: Arizona
city: Little Rock
country: United States
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state: Arkansas
city: Arcadia
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state: California
city: Beverly Hills
country: United States
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state: California
city: Carson
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state: California
city: Cerritos
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city: Chino
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city: Costa Mesa
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city: Encino
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city: Garden Grove
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city: Irvine
country: United States
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city: Los Alamitos
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city: Los Angeles
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city: Newport Beach
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city: Pico Rivera
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city: Riverside
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city: Sherman Oaks
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city: Denver
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city: Norwalk
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city: Norwich
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city: Bradenton
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state: Florida
city: Coral Springs
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city: Ft Myers
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city: West Palm Beach
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city: Roswell
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state: Georgia
city: Chicago
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state: Illinois
city: Hoffman Estates
country: United States
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state: Illinois
city: Joliet
country: United States
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state: Illinois
city: Schaumburg
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city: Skokie
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state: Illinois
city: Lafayette
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city: Valparaiso
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city: Prairie Village
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city: Wichita
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city: Florence
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state: Kentucky
city: Shreveport
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state: Louisiana
city: Baltimore
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state: Maryland
city: Gaithersburg
country: United States
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state: Maryland
city: Glen Burnie
country: United States
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state: Maryland
city: Rockville
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state: Maryland
city: Weymouth
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state: Massachusetts
city: Flowood
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state: Mississippi
city: Creve Coeur
country: United States
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state: Missouri
city: St. Louis
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state: Missouri
city: Lincoln
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state: Nebraska
city: Toms River
country: United States
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state: New Jersey
city: Willingboro
country: United States
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state: New Jersey
city: Albuquerque
country: United States
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state: New Mexico
city: Fresh Meadows
country: United States
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state: New York
city: Mount Kisco
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Rochester
country: United States
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state: New York
city: Staten Island
country: United States
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state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
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state: North Carolina
city: Beechwood
country: United States
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state: Ohio
city: Canton
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Dublin
country: United States
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state: Ohio
city: Mason
country: United States
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state: Ohio
city: Middleburg Heights
country: United States
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state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Portland
country: United States
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state: Oregon
city: Salem
country: United States
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state: Oregon
city: Jenkintown
country: United States
facility: Research Site
state: Pennsylvania
city: Norristown
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Austin
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Friendswood
country: United States
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state: Texas
city: Irving
country: United States
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state: Texas
city: Lake Jackson
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Woodstock
country: United States
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state: Vermont
city: Seattle
country: United States
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state: Washington
city: South Kirkland
country: United States
facility: Research Site
state: Washington
city: Middleton
country: United States
facility: Research Site
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Hans A. Eriksson, MD, Ph.D, MBA
role: STUDY_DIRECTOR
affiliation: Florida Clinical Research Center, LLC
name: Andrew . J Cutler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.