Text Size

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
History of Changes
  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:

U.S. FDA Resources

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

  Show 67 Study Locations
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:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Duloxetine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on May 19, 2013