Efficacy and Safety Study of ABT-436 in Major Depressive Disorder

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: ABT-436; Drug: Escitalopram; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01741142

M11-733

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 3 patient groups, including a placebo group

ABT-436

Experimental group

Description:

Subject receiving ABT-436

Treatment:

Drug: ABT-436

Escitalopram

Active Comparator group

Description:

Subject receiving escitalopram.

Treatment:

Drug: Escitalopram

Placebo

Placebo Comparator group

Description:

Subject receiving placebo

Treatment:

Drug: Placebo