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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01288079
Recruitment Status : Terminated
First Posted : February 2, 2011
Results First Posted : October 29, 2012
Last Update Posted : November 20, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Drug: TC-5214 Drug: Duloxetine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : February 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Duloxetine

Arm Intervention/treatment
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
Drug: Placebo
Tablet, oral, twice daily for 8 weeks

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01288079

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Sponsors and Collaborators
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Study Director: Hans A Eriksson, MD, PhD, MBA AstraZeneca R&D Södertälje

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Responsible Party: AstraZeneca Identifier: NCT01288079     History of Changes
Other Study ID Numbers: D4131C00001
First Posted: February 2, 2011    Key Record Dates
Results First Posted: October 29, 2012
Last Update Posted: November 20, 2012
Last Verified: November 2012
Keywords provided by AstraZeneca:
Major Depressive Disorder
Inadequate Response to Antidepressant Therapy
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Dopamine Agents