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Trial record 2 of 1950 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Major Depressive Disorder

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) )

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date October 8, 2013
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01741142 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder
Brief Summary The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: ABT-436
    Subjects receiving ABT-436
  • Drug: Escitalopram
    Subjects receiving escitalopram
  • Drug: Placebo
    Subject receiving placebo
Study Arms  ICMJE
  • Experimental: ABT-436
    Subject receiving ABT-436
    Intervention: Drug: ABT-436
  • Active Comparator: Escitalopram
    Subject receiving escitalopram.
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Subject receiving placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 4, 2013)
19
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
216
Estimated Study Completion Date  ICMJE August 2015
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741142
Other Study ID Numbers  ICMJE M11-733
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Beatrice Rendenbach-Mueller, PhD AbbVie
PRS Account AbbVie
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP