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

• ClinicalTrials.gov Identifier: NCT01741142
• Recruitment Status: Terminated
• First Posted: December 4, 2012
• Last Update Posted: October 8, 2013
• Sponsor: AbbVie (prior sponsor, Abbott)
• Information provided by (Responsible Party): AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information

• First Submitted Date: November 30, 2012
• First Posted Date: December 4, 2012
• Last Update Posted Date: October 8, 2013
• Study Start Date: January 2012
• Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

• Drug: ABT-436
  Subjects receiving ABT-436
• Drug: Escitalopram
  Subjects receiving escitalopram
• Drug: Placebo
  Subject receiving placebo

Study Arms

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 4, 2013): 19
• Original Estimated Enrollment (submitted: November 30, 2012): 216
• Estimated Study Completion Date: August 2015
• Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01741142
• Other Study ID Numbers: M11-733
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
• Study Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborators: Not Provided

Investigators

• Study Director: Beatrice Rendenbach-Mueller, PhD; AbbVie

• PRS Account: AbbVie
• Verification Date: October 2013