Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
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ClinicalTrials.gov Identifier: NCT01741142 |
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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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 |

Arm | Intervention/treatment |
---|---|
Experimental: ABT-436
Subject receiving ABT-436
|
Drug: ABT-436
Subjects receiving ABT-436 |
Active Comparator: Escitalopram
Subject receiving escitalopram.
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Drug: Escitalopram
Subjects receiving escitalopram |
Placebo Comparator: Placebo
Subject receiving placebo
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Drug: Placebo
Subject receiving placebo |
- 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 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.

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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 |
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.

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

Study Director: | Beatrice Rendenbach-Mueller, PhD | AbbVie |
Responsible Party: | AbbVie (prior sponsor, Abbott) |
ClinicalTrials.gov Identifier: | NCT01741142 |
Other Study ID Numbers: |
M11-733 |
First Posted: | December 4, 2012 Key Record Dates |
Last Update Posted: | October 8, 2013 |
Last Verified: | October 2013 |
Major Depressive Disorder |
Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms 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 |