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Efficacy and Safety Study of ABT-436 in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01741142
Recruitment Status : Terminated (Decision based on strategic determination; not safety.)
First Posted : December 4, 2012
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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Brief Summary:
The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: ABT-436 Drug: Escitalopram Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder
Study Start Date : January 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : August 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ABT-436
Subject receiving ABT-436
 Drug: ABT-436
Subjects receiving ABT-436
Active Comparator: Escitalopram
Subject receiving escitalopram.
 Drug: Escitalopram
Subjects receiving escitalopram
Placebo Comparator: Placebo
Subject receiving placebo
 Drug: Placebo
Subject receiving placebo


Outcome Measures
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Primary Outcome Measures :
  1. Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score. [ Time Frame: Week 6 ]
    Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.


Secondary Outcome Measures :
  1. Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale. [ Time Frame: Week 6 ]
    Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Has a primary Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision diagnosis of major depressive disorder without psychotic features
  • No current antidepressant treatment within 7 half-lives or 2 weeks, whichever is longer, prior to Day minus 1.
  • Can safely be treated on an outpatient basis.
  • A condition of general good physical health.
  • Surgically sterile, using a highly effective method of birth control or (if female) at least 1 year post menopausal.

Exclusion Criteria:

  • History of hypersensitivity, intolerance or adverse reaction to escitalopram that led to discontinuation, or hypersensitivity to citalopram. History of serotonin syndrome.
  • Inadequate response to more than two different antidepressant medications during the current major depressive episode.
  • History of electroconvulsive therapy, vagal nerve stimulation or deep brain stimulation.
  • History of transcranial magnetic stimulation during the current major depressive episode.
  • Psychotherapy that has not been ongoing for at least 3 months prior to Day minus 1.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01741142


Locations
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Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Director: Beatrice Rendenbach-Mueller, PhD AbbVie
More Information
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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01741142    
Other Study ID Numbers: M11-733
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Major Depressive Disorder
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Serotonin Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs