A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

November 14, 2012 updated by: AstraZeneca

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Active Controlled, Parallel Group, Multicenter Study to Assess the Safety and Efficacy of 2 Fixed Dose Groups of TC-5214 (S-mecamylamine) as Monotherapy Treatment in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 2

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

  • Estonia
      • Tallin, Estonia
        • Research Site
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Jyväskylä, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
  • India
      • Kanpur, India
        • Research Site
      • Pune, India
        • Research Site
    • Andh Prad
      • Visakhapatnam, Andh Prad, India
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Research Site
    • Kamataka
      • Bangalore, Kamataka, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
      • Mangalore, Karnataka, India
        • Research Site
    • Mahara
      • Nashik, Mahara, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Research Site
    • Uttar Prad
      • Varanasi, Uttar Prad, India
        • Research Site
  • Japan
      • Kumamoto, Japan
        • Research Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Research Site
    • Chiba
      • Ichikawa, Chiba, Japan
        • Research Site
      • Noda City, Chiba, Japan
        • Research Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan
        • Research Site
      • Omuta-City, Fukuoka, Japan
        • Research Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Research Site
      • Sapporo-shi, Hokkaido, Japan
        • Research Site
      • Sapproro, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Akashi, Hyogo, Japan
        • Research Site
      • Kobe, Hyogo, Japan
        • Research Site
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan
        • Research Site
      • Sagamihara-shi, Kanagawa, Japan
        • Research Site
      • Yokohama-city, Kanagawa, Japan
        • Research Site
      • Yokohama-shi, Kanagawa, Japan
        • Research Site
    • Kumamoto
      • Yatsushiro, Kumamoto, Japan
        • Research Site
      • Yatsushiro-city, Kumamoto, Japan
        • Research Site
    • Kyoto
      • Ukyo-ku ,Kyoto, Kyoto, Japan
        • Research Site
    • Okayama
      • Kurashiki-shi, Okayama, Japan
        • Research Site
    • Tokyo
      • Kodaira-shi, Tokyo, Japan
        • Research Site
      • Meguro-ku, Tokyo, Japan
        • Research Site
      • Minato-ku, Tokyo, Japan
        • Research Site
      • Setagaya-ku, Tokyo, Japan
        • Research Site
      • Shinagawa-ku, Tokyo, Japan
        • Research Site
  • United States
    • California
      • Beverly Hills, California, United States
        • Research Site
      • Chino, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
    • Florida
      • Bradenton, Florida, United States
        • Research Site
      • Coral Springs, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • North Miami, Florida, United States
        • Research Site
      • St Petersburg, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Illinois
      • Joliet, Illinois, United States
        • Research Site
    • Kansas
      • Prairie Village, Kansas, United States
        • Research Site
    • Mississippi
      • Flowood, Mississippi, United States
        • Research Site
    • New York
      • New York, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • Ohio
      • Dayton, Ohio, United States
        • Research Site
      • Mason, Ohio, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Research Site
    • Wisconsin
      • Madison, 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.
  • Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
  • 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 any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
  • History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
  • Pregnancy or lactation.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
Placebo
Drug: Placebo
Tablet, oral, twice daily for 8 weeks
Experimental: 1
TC-5214, 1 mg BID
Drug: TC-5214
Tablet, oral, twice daily for 8 weeks
Experimental: 2
TC-5214, 4 mg BID
Drug: TC-5214
Tablet, oral, twice daily for 8 weeks
Active Comparator: 3
Duloxetine 60 mg Q Day
Drug: Duloxetine
Capsule, oral, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment
Time Frame: Randomization (Week 8) to end of treatment (Week 16)
A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (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)

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Hans A Eriksson, MD, PhD, MBA, AstraZeneca R&D Södertälje

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

February 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

February 1, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4131C00001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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