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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01288079
First received: January 26, 2011
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: TC-5214
Drug: Duloxetine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 145
Study Start Date: February 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: 4
Placebo
Drug: Placebo
Tablet, oral, twice daily for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288079

  Hide Study Locations
Locations
United States, California
Research Site
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
United States, Florida
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Bradenton, Florida, United States
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Coral Springs, Florida, United States
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Jacksonville, Florida, United States
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North Miami, Florida, United States
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St Petersburg, Florida, United States
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West Palm Beach, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
United States, Illinois
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Joliet, Illinois, United States
United States, Kansas
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Prairie Village, Kansas, United States
United States, Mississippi
Research Site
Flowood, Mississippi, United States
United States, New York
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New York, New York, United States
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Rochester, New York, United States
United States, Ohio
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Dayton, Ohio, United States
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Mason, Ohio, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Pennsylvania
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Allentown, Pennsylvania, United States
United States, Texas
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Dallas, Texas, United States
Research Site
Houston, Texas, United States
United States, Washington
Research Site
Seattle, Washington, United States
United States, Wisconsin
Research Site
Madison, Wisconsin, United States
Estonia
Research Site
Tallin, Estonia
Research Site
Tallinn, Estonia
Research Site
Tartu, Estonia
Finland
Research Site
Helsinki, Finland
Research Site
Jyväskylä, Finland
Research Site
Kuopio, Finland
Research Site
Tampere, Finland
India
Research Site
Visakhapatnam, Andh Prad, India
Research Site
Ahmedabad, Gujarat, India
Research Site
Bangalore, Kamataka, India
Research Site
Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Nashik, Mahara, India
Research Site
Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
Research Site
Varanasi, Uttar Prad, India
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Kanpur, India
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Pune, India
Japan
Research Site
Nagoya, Aichi, Japan
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Ichikawa, Chiba, Japan
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Noda City, Chiba, Japan
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Fukuoka-city, Fukuoka, Japan
Research Site
Omuta-City, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Sapporo-shi, Hokkaido, Japan
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Sapproro, Hokkaido, Japan
Research Site
Akashi, Hyogo, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Kawasaki-shi, Kanagawa, Japan
Research Site
Sagamihara-shi, Kanagawa, Japan
Research Site
Yokohama-city, Kanagawa, Japan
Research Site
Yokohama-shi, Kanagawa, Japan
Research Site
Yatsushiro, Kumamoto, Japan
Research Site
Yatsushiro-city, Kumamoto, Japan
Research Site
Ukyo-ku ,Kyoto, Kyoto, Japan
Research Site
Kurashiki-shi, Okayama, Japan
Research Site
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
Kumamoto, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans A Eriksson, MD, PhD, MBA AstraZeneca R&D Södertälje
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01288079     History of Changes
Other Study ID Numbers: D4131C00001
Study First Received: January 26, 2011
Results First Received: August 7, 2012
Last Updated: November 14, 2012
Health Authority: Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
India: Drugs Controller General of India
Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Major Depressive Disorder
MDD
Monotherapy
Inadequate Response to Antidepressant Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Antidepressive Agents
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014