A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder

AbbVie (prior sponsor, Abbott)18 sites in 1 country19 target enrollmentJanuary 2012

Overview

Phase: Phase 2
Intervention: ABT-436
Conditions: Major Depressive Disorder
Sponsor: AbbVie (prior sponsor, Abbott)
Enrollment: 19
Locations: 18
Primary Endpoint: Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
Status: Terminated
Last Updated: 12 years ago

The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

August 2015

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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
•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.