Study Stopped
Decision based on strategic determination; not safety.
Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder
1 other identifier
interventional
19
1 country
18
Brief Summary
The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 major-depressive-disorder
Started Jan 2012
Longer than P75 for phase_2 major-depressive-disorder
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 30, 2012
CompletedFirst Posted
Study publicly available on registry
December 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedOctober 8, 2013
October 1, 2013
1.8 years
November 30, 2012
October 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
Week 6
Secondary Outcomes (1)
Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.
Week 6
Study Arms (3)
ABT-436
EXPERIMENTALSubject receiving ABT-436
Escitalopram
ACTIVE COMPARATORSubject receiving escitalopram.
Placebo
PLACEBO COMPARATORSubject receiving placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Site Reference ID/Investigator# 85593
Little Rock, Arkansas, 72211, United States
Site Reference ID/Investigator# 87228
Garden Grove, California, 92845, United States
Site Reference ID/Investigator# 87214
National City, California, 91950, United States
Site Reference ID/Investigator# 87220
Oakland, California, 94612, United States
Site Reference ID/Investigator# 87215
Bradenton, Florida, 34201, United States
Site Reference ID/Investigator# 87225
South Miami, Florida, 33143, United States
Site Reference ID/Investigator# 85594
Atlanta, Georgia, 30328, United States
Site Reference ID/Investigator# 85580
Marlton, New Jersey, 08053, United States
Site Reference ID/Investigator# 87227
Brooklyn, New York, 11235, United States
Site Reference ID/Investigator# 87223
New York, New York, 10128, United States
Site Reference ID/Investigator# 87217
Dayton, Ohio, 45417, United States
Site Reference ID/Investigator# 87226
Portland, Oregon, 97210, United States
Site Reference ID/Investigator# 87221
Philadelphia, Pennsylvania, 19139, United States
Site Reference ID/Investigator# 87219
Austin, Texas, 78731, United States
Site Reference ID/Investigator# 87216
Dallas, Texas, 75231, United States
Site Reference ID/Investigator# 87933
Houston, Texas, 77008, United States
Site Reference ID/Investigator# 88874
Salt Lake City, Utah, 84106, United States
Site Reference ID/Investigator# 88876
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Beatrice Rendenbach-Mueller, PhD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2012
First Posted
December 4, 2012
Study Start
January 1, 2012
Primary Completion
October 1, 2013
Study Completion
August 1, 2015
Last Updated
October 8, 2013
Record last verified: 2013-10