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Trial record 29 of 1863 for:    "Depressive Disorder" [DISEASE] | "Depressive Disorder, Major"

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) )

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 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

Resource links provided by the National Library of Medicine


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




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.



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
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.

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
United States, Arkansas
Site Reference ID/Investigator# 85593
Little Rock, Arkansas, United States, 72211
United States, California
Site Reference ID/Investigator# 87228
Garden Grove, California, United States, 92845
Site Reference ID/Investigator# 87214
National City, California, United States, 91950
Site Reference ID/Investigator# 87220
Oakland, California, United States, 94612
United States, Florida
Site Reference ID/Investigator# 87215
Bradenton, Florida, United States, 34201
Site Reference ID/Investigator# 87225
South Miami, Florida, United States, 33143
United States, Georgia
Site Reference ID/Investigator# 85594
Atlanta, Georgia, United States, 30328
United States, New Jersey
Site Reference ID/Investigator# 85580
Marlton, New Jersey, United States, 08053
United States, New York
Site Reference ID/Investigator# 87227
Brooklyn, New York, United States, 11235
Site Reference ID/Investigator# 87223
New York, New York, United States, 10128
United States, Ohio
Site Reference ID/Investigator# 87217
Dayton, Ohio, United States, 45417
United States, Oregon
Site Reference ID/Investigator# 87226
Portland, Oregon, United States, 97210
United States, Pennsylvania
Site Reference ID/Investigator# 87221
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Site Reference ID/Investigator# 87219
Austin, Texas, United States, 78731
Site Reference ID/Investigator# 87216
Dallas, Texas, United States, 75231
Site Reference ID/Investigator# 87933
Houston, Texas, United States, 77008
United States, Utah
Site Reference ID/Investigator# 88874
Salt Lake City, Utah, United States, 84106
United States, Washington
Site Reference ID/Investigator# 88876
Seattle, Washington, United States, 98104
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Beatrice Rendenbach-Mueller, PhD AbbVie

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01741142     History of Changes
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:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Dexetimide
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents