- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01741142
Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
October 4, 2013 updated by: AbbVie (prior sponsor, Abbott)
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder
The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Site Reference ID/Investigator# 85593
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California
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Garden Grove, California, United States, 92845
- Site Reference ID/Investigator# 87228
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National City, California, United States, 91950
- Site Reference ID/Investigator# 87214
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Oakland, California, United States, 94612
- Site Reference ID/Investigator# 87220
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Florida
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Bradenton, Florida, United States, 34201
- Site Reference ID/Investigator# 87215
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South Miami, Florida, United States, 33143
- Site Reference ID/Investigator# 87225
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Georgia
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Atlanta, Georgia, United States, 30328
- Site Reference ID/Investigator# 85594
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New Jersey
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Marlton, New Jersey, United States, 08053
- Site Reference ID/Investigator# 85580
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New York
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Brooklyn, New York, United States, 11235
- Site Reference ID/Investigator# 87227
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New York, New York, United States, 10128
- Site Reference ID/Investigator# 87223
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Ohio
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Dayton, Ohio, United States, 45417
- Site Reference ID/Investigator# 87217
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Oregon
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Portland, Oregon, United States, 97210
- Site Reference ID/Investigator# 87226
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19139
- Site Reference ID/Investigator# 87221
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Texas
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Austin, Texas, United States, 78731
- Site Reference ID/Investigator# 87219
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Dallas, Texas, United States, 75231
- Site Reference ID/Investigator# 87216
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Houston, Texas, United States, 77008
- Site Reference ID/Investigator# 87933
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Utah
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Salt Lake City, Utah, United States, 84106
- Site Reference ID/Investigator# 88874
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Washington
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Seattle, Washington, United States, 98104
- Site Reference ID/Investigator# 88876
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABT-436
Subject receiving ABT-436
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Subjects receiving ABT-436
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Active Comparator: Escitalopram
Subject receiving escitalopram.
|
Subjects receiving escitalopram
|
Placebo Comparator: Placebo
Subject receiving placebo
|
Subject receiving placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Beatrice Rendenbach-Mueller, PhD, AbbVie
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
August 1, 2015
Study Registration Dates
First Submitted
November 30, 2012
First Submitted That Met QC Criteria
November 30, 2012
First Posted (Estimate)
December 4, 2012
Study Record Updates
Last Update Posted (Estimate)
October 8, 2013
Last Update Submitted That Met QC Criteria
October 4, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- M11-733
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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