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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01741142

Enrollment

Registered

2012-12-04

Start date

2012-01-31

Completion date

2015-08-31

Last updated

2013-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder

Brief summary

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

Interventions

DRUGABT-436

Subjects receiving ABT-436

DRUGEscitalopram

Subjects receiving escitalopram

DRUGPlacebo

Subject receiving placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.	Week 6	Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.

Secondary

Measure	Time frame	Description
Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.	Week 6	Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026