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

October 4, 2013 updated by: AbbVie (prior sponsor, Abbott)

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Site Reference ID/Investigator# 85593
    • California
      • Garden Grove, California, United States, 92845
        • Site Reference ID/Investigator# 87228
      • National City, California, United States, 91950
        • Site Reference ID/Investigator# 87214
      • Oakland, California, United States, 94612
        • Site Reference ID/Investigator# 87220
    • Florida
      • Bradenton, Florida, United States, 34201
        • Site Reference ID/Investigator# 87215
      • South Miami, Florida, United States, 33143
        • Site Reference ID/Investigator# 87225
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Site Reference ID/Investigator# 85594
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Site Reference ID/Investigator# 85580
    • New York
      • Brooklyn, New York, United States, 11235
        • Site Reference ID/Investigator# 87227
      • New York, New York, United States, 10128
        • Site Reference ID/Investigator# 87223
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Site Reference ID/Investigator# 87217
    • Oregon
      • Portland, Oregon, United States, 97210
        • Site Reference ID/Investigator# 87226
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Site Reference ID/Investigator# 87221
    • Texas
      • Austin, Texas, United States, 78731
        • Site Reference ID/Investigator# 87219
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 87216
      • Houston, Texas, United States, 77008
        • Site Reference ID/Investigator# 87933
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Site Reference ID/Investigator# 88874
    • Washington
      • Seattle, Washington, United States, 98104
        • Site Reference ID/Investigator# 88876

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABT-436
Subject receiving ABT-436
Drug: ABT-436
Subjects receiving ABT-436
Active Comparator: Escitalopram
Subject receiving escitalopram.
Drug: Escitalopram
Subjects receiving escitalopram
Placebo Comparator: Placebo
Subject receiving placebo
Drug: Placebo
Subject receiving placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Beatrice Rendenbach-Mueller, PhD, AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 4, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M11-733

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on ABT-436

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe