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

Primary Purpose

Major Depressive Disorder

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-436
Escitalopram
Placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Site Reference ID/Investigator# 85593
  • Site Reference ID/Investigator# 87228
  • Site Reference ID/Investigator# 87214
  • Site Reference ID/Investigator# 87220
  • Site Reference ID/Investigator# 87215
  • Site Reference ID/Investigator# 87225
  • Site Reference ID/Investigator# 85594
  • Site Reference ID/Investigator# 85580
  • Site Reference ID/Investigator# 87227
  • Site Reference ID/Investigator# 87223
  • Site Reference ID/Investigator# 87217
  • Site Reference ID/Investigator# 87226
  • Site Reference ID/Investigator# 87221
  • Site Reference ID/Investigator# 87219
  • Site Reference ID/Investigator# 87216
  • Site Reference ID/Investigator# 87933
  • Site Reference ID/Investigator# 88874
  • Site Reference ID/Investigator# 88876

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

ABT-436

Escitalopram

Placebo

Arm Description

Subject receiving ABT-436

Subject receiving escitalopram.

Subject receiving placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 30, 2012
Last Updated
October 4, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01741142
Brief Title
Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Decision based on strategic determination; not safety.
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-436
Arm Type
Experimental
Arm Description
Subject receiving ABT-436
Arm Title
Escitalopram
Arm Type
Active Comparator
Arm Description
Subject receiving escitalopram.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subject receiving placebo
Intervention Type
Drug
Intervention Name(s)
ABT-436
Intervention Description
Subjects receiving ABT-436
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
Subjects receiving escitalopram
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subject receiving placebo
Primary Outcome Measure Information:
Title
Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score.
Description
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
Secondary Outcome Measure Information:
Title
Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.
Description
Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatrice Rendenbach-Mueller, PhD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 85593
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Site Reference ID/Investigator# 87228
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Site Reference ID/Investigator# 87214
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Site Reference ID/Investigator# 87220
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Site Reference ID/Investigator# 87215
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Site Reference ID/Investigator# 87225
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Site Reference ID/Investigator# 85594
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Site Reference ID/Investigator# 85580
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Site Reference ID/Investigator# 87227
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Site Reference ID/Investigator# 87223
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Site Reference ID/Investigator# 87217
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Site Reference ID/Investigator# 87226
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Site Reference ID/Investigator# 87221
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Site Reference ID/Investigator# 87219
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Site Reference ID/Investigator# 87216
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site Reference ID/Investigator# 87933
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Site Reference ID/Investigator# 88874
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Site Reference ID/Investigator# 88876
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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