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

March 14, 2014 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

813

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SSRI/Serotonin/SNRI + TC-5214 1-4 mg
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 mg BID
Drug: TC-5214
Tablet, oral, twice daily for 52 weeks
Placebo Comparator: SSRI/Serotonin/SNRI + placebo
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + placebo BID
Drug: Placebo
Tablet, oral, twice daily for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Patients Experiencing at Least One Adverse Event (AE)
Time Frame: Randomization (Week 0) to end of the follow-up period (Week 54)
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)
Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
Time Frame: Randomization (Week 0) to end of the follow-up period (Week 54)
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)
Frequency of Patients Experiencing Serious Adverse Events (SAEs)
Time Frame: Randomization (Week 0) to end of the follow-up period (Week 54)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Week 12 to 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
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
Time Frame: Week 12 to 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
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)
Time Frame: 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)
Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score
Time Frame: Randomization (Week 0) to end of treatment (Week 52)
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)
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
Time Frame: Randomization (Week 0) to end of treatment (Week 52)
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)
Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Targacept Inc.

Investigators

  • Study Director: Hans A. Eriksson, MD, Ph.D, MBA, AstraZeneca
  • Principal Investigator: Andrew . J Cutler, MD, Florida Clinical Research Center, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4130C00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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