Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
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| ClinicalTrials.gov Identifier: NCT01741142 |
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Recruitment Status :
Terminated
(Decision based on strategic determination; not safety.)
First Posted : December 4, 2012
Last Update Posted : October 8, 2013
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Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
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Brief Summary:
The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: ABT-436 Drug: Escitalopram Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 19 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder |
| Study Start Date : | January 2012 |
| Estimated Primary Completion Date : | October 2013 |
| Estimated Study Completion Date : | August 2015 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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Experimental: ABT-436
Subject receiving ABT-436
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Drug: ABT-436
Subjects receiving ABT-436 |
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Active Comparator: Escitalopram
Subject receiving escitalopram.
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Drug: Escitalopram
Subjects receiving escitalopram |
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Placebo Comparator: Placebo
Subject receiving placebo
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Drug: Placebo
Subject receiving placebo |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741142
Locations
| United States, Arkansas | |
| Site Reference ID/Investigator# 85593 | |
| Little Rock, Arkansas, United States, 72211 | |
| United States, California | |
| Site Reference ID/Investigator# 87228 | |
| Garden Grove, California, United States, 92845 | |
| Site Reference ID/Investigator# 87214 | |
| National City, California, United States, 91950 | |
| Site Reference ID/Investigator# 87220 | |
| Oakland, California, United States, 94612 | |
| United States, Florida | |
| Site Reference ID/Investigator# 87215 | |
| Bradenton, Florida, United States, 34201 | |
| Site Reference ID/Investigator# 87225 | |
| South Miami, Florida, United States, 33143 | |
| United States, Georgia | |
| Site Reference ID/Investigator# 85594 | |
| Atlanta, Georgia, United States, 30328 | |
| United States, New Jersey | |
| Site Reference ID/Investigator# 85580 | |
| Marlton, New Jersey, United States, 08053 | |
| United States, New York | |
| Site Reference ID/Investigator# 87227 | |
| Brooklyn, New York, United States, 11235 | |
| Site Reference ID/Investigator# 87223 | |
| New York, New York, United States, 10128 | |
| United States, Ohio | |
| Site Reference ID/Investigator# 87217 | |
| Dayton, Ohio, United States, 45417 | |
| United States, Oregon | |
| Site Reference ID/Investigator# 87226 | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Site Reference ID/Investigator# 87221 | |
| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Texas | |
| Site Reference ID/Investigator# 87219 | |
| Austin, Texas, United States, 78731 | |
| Site Reference ID/Investigator# 87216 | |
| Dallas, Texas, United States, 75231 | |
| Site Reference ID/Investigator# 87933 | |
| Houston, Texas, United States, 77008 | |
| United States, Utah | |
| Site Reference ID/Investigator# 88874 | |
| Salt Lake City, Utah, United States, 84106 | |
| United States, Washington | |
| Site Reference ID/Investigator# 88876 | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Beatrice Rendenbach-Mueller, PhD | AbbVie |
| Responsible Party: | AbbVie (prior sponsor, Abbott) |
| ClinicalTrials.gov Identifier: | NCT01741142 History of Changes |
| Other Study ID Numbers: |
M11-733 |
| First Posted: | December 4, 2012 Key Record Dates |
| Last Update Posted: | October 8, 2013 |
| Last Verified: | October 2013 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
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Major Depressive Disorder |
Additional relevant MeSH terms:
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Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Dexetimide Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |