A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152554
• Other study ID #: D4130C00007
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2010
• Last updated: March 14, 2014
• Start date: June 2010
• Est. completion date: February 2012

Study information

• Verified date: March 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 813
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• MDD

Intervention

Drug:
• TC-5214
Tablet, oral, twice daily for 52 weeks
• Placebo
Tablet, oral, twice daily for 52 weeks

Locations

Country	Name	City	State
Puerto Rico	Research Site	San Juan
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Arcadia	California
United States	Research Site	Austin	Texas
United States	Research Site	Baltimore	Maryland
United States	Research Site	Beechwood	Ohio
United States	Research Site	Beverly Hills	California
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bradenton	Florida
United States	Research Site	Canton	Ohio
United States	Research Site	Carson	California
United States	Research Site	Cerritos	California
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Chino	California
United States	Research Site	Coral Springs	Florida
United States	Research Site	Costa Mesa	California
United States	Research Site	Creve Coeur	Missouri
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Dublin	Ohio
United States	Research Site	Encino	California
United States	Research Site	Escondido	California
United States	Research Site	Florence	Kentucky
United States	Research Site	Flowood	Mississippi
United States	Research Site	Fresh Meadows	New York
United States	Research Site	Friendswood	Texas
United States	Research Site	Ft Myers	Florida
United States	Research Site	Gainsville	Florida
United States	Research Site	Gaithersburg	Maryland
United States	Research Site	Garden Grove	California
United States	Research Site	Glen Burnie	Maryland
United States	Research Site	Hoffman Estates	Illinois
United States	Research Site	Irvine	California
United States	Research Site	Irving	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jenkintown	Pennsylvania
United States	Research Site	Joliet	Illinois
United States	Research Site	Lafayette	Indiana
United States	Research Site	Lake Jackson	Texas
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Los Alamitos	California
United States	Research Site	Los Angeles	California
United States	Research Site	Maitland	Florida
United States	Research Site	Mason	Ohio
United States	Research Site	Middleburg Heights	Ohio
United States	Research Site	Middleton	Wisconsin
United States	Research Site	Mount Kisco	New York
United States	Research Site	New York	New York
United States	Research Site	Newport Beach	California
United States	Research Site	Norristown	Pennsylvania
United States	Research Site	North Miami	Florida
United States	Research Site	Norwalk	Connecticut
United States	Research Site	Norwich	Connecticut
United States	Research Site	Orange City	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Pico Rivera	California
United States	Research Site	Pinecrest	Florida
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plantation	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Prairie Village	Kansas
United States	Research Site	Riverside	California
United States	Research Site	Rochester	New York
United States	Research Site	Rockville	Maryland
United States	Research Site	Roswell	Georgia
United States	Research Site	Salem	Oregon
United States	Research Site	San Antonio	Texas
United States	Research Site	Schaumburg	Illinois
United States	Research Site	Seattle	Washington
United States	Research Site	Sherman Oaks	California
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Skokie	Illinois
United States	Research Site	South Kirkland	Washington
United States	Research Site	St Petersburg	Florida
United States	Research Site	St. Louis	Missouri
United States	Research Site	Staten Island	New York
United States	Research Site	Tampa	Florida
United States	Research Site	Toledo	Ohio
United States	Research Site	Toms River	New Jersey
United States	Research Site	Torrance	California
United States	Research Site	Tucson	Arizona
United States	Research Site	Tuscaloosa	Alabama
United States	Research Site	Upland	California
United States	Research Site	Valparaiso	Indiana
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Weymouth	Massachusetts
United States	Research Site	Wichita	Kansas
United States	Research Site	Willingboro	New Jersey
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Woodstock	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Targacept Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Patients Experiencing at Least One Adverse Event (AE)	The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.	Randomization (Week 0) to end of the follow-up period (Week 54)	No
Primary	Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)	The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.	Randomization (Week 0) to end of the follow-up period (Week 54)	No
Primary	Frequency of Patients Experiencing Serious Adverse Events (SAEs)	The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.	Randomization (Week 0) to end of the follow-up period (Week 54)	No
Secondary	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	The percentage of patients with a a MADRS total score of =12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but =16 or missing was allowed from Week 16 to Week 20.; 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.	Week 12 to Week 24	No
Secondary	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	The percentage of patients with a MADRS total score of =12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but =16 or missing were allowed from Week 16 to Week 48.; 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.	Week 12 to Week 52	No
Secondary	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)	A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.	Randomization (Week 0) to end of treatment (Week 52)	No
Secondary	Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score	Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).	Randomization (Week 0) to end of treatment (Week 52)	No
Secondary	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	The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.	Randomization (Week 0) to end of treatment (Week 52)	No
Secondary	Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)	A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.	Randomization (Week 0) to end of treatment (Week 52)	No

External Links

•   CSR-D4130C00007.pdf
•   D4130C00007/Clinical Study Protocol