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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01741142
• Other study ID #: M11-733
• Status: Terminated
• Phase: Phase 2
• First received: November 30, 2012
• Last updated: October 4, 2013
• Start date: January 2012
• Est. completion date: August 2015

Study information

• Verified date: October 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: August 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• ABT-436
Subjects receiving ABT-436
• Escitalopram
Subjects receiving escitalopram
• Placebo
Subject receiving placebo

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 85594	Atlanta	Georgia
United States	Site Reference ID/Investigator# 87219	Austin	Texas
United States	Site Reference ID/Investigator# 87215	Bradenton	Florida
United States	Site Reference ID/Investigator# 87227	Brooklyn	New York
United States	Site Reference ID/Investigator# 87216	Dallas	Texas
United States	Site Reference ID/Investigator# 87217	Dayton	Ohio
United States	Site Reference ID/Investigator# 87228	Garden Grove	California
United States	Site Reference ID/Investigator# 87933	Houston	Texas
United States	Site Reference ID/Investigator# 85593	Little Rock	Arkansas
United States	Site Reference ID/Investigator# 85580	Marlton	New Jersey
United States	Site Reference ID/Investigator# 87214	National City	California
United States	Site Reference ID/Investigator# 87223	New York	New York
United States	Site Reference ID/Investigator# 87220	Oakland	California
United States	Site Reference ID/Investigator# 87221	Philadelphia	Pennsylvania
United States	Site Reference ID/Investigator# 87226	Portland	Oregon
United States	Site Reference ID/Investigator# 88874	Salt Lake City	Utah
United States	Site Reference ID/Investigator# 88876	Seattle	Washington
United States	Site Reference ID/Investigator# 87225	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.	Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.	Week 6	No
Secondary	Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.	Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.	Week 6	No