Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT01741142
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subject receiving placebo ABT-436 ABT-436 Subject receiving ABT-436 Escitalopram Escitalopram Subject receiving escitalopram.
- Primary Outcome Measures
Name Time Method Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score. 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
Name Time Method Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale. Week 6 Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.
Trial Locations
- Locations (18)
Site Reference ID/Investigator# 87225
🇺🇸South Miami, Florida, United States
Site Reference ID/Investigator# 87226
🇺🇸Portland, Oregon, United States
Site Reference ID/Investigator# 88876
🇺🇸Seattle, Washington, United States
Site Reference ID/Investigator# 87228
🇺🇸Garden Grove, California, United States
Site Reference ID/Investigator# 87217
🇺🇸Dayton, Ohio, United States
Site Reference ID/Investigator# 87221
🇺🇸Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 85593
🇺🇸Little Rock, Arkansas, United States
Site Reference ID/Investigator# 87220
🇺🇸Oakland, California, United States
Site Reference ID/Investigator# 85594
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 87216
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 87214
🇺🇸National City, California, United States
Site Reference ID/Investigator# 87933
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 85580
🇺🇸Marlton, New Jersey, United States
Site Reference ID/Investigator# 87215
🇺🇸Bradenton, Florida, United States
Site Reference ID/Investigator# 87223
🇺🇸New York, New York, United States
Site Reference ID/Investigator# 87227
🇺🇸Brooklyn, New York, United States
Site Reference ID/Investigator# 87219
🇺🇸Austin, Texas, United States
Site Reference ID/Investigator# 88874
🇺🇸Salt Lake City, Utah, United States