Lethargic Depression Study

May 24, 2017 updated by: GlaxoSmithKline

An 8 Week, Multicenter, Randomized, Double-blind, Placebo Controlled Comparison of the Efficacy of Extended Release Bupropion Hydrochloride and Placebo in the Treatment of Adult Outpatients With Major Depressive Disorder With Lethargic Symptoms

This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Multicenter, Double-Blind, Placebo-controlled comparison of the efficacy and safety of flexible dose extended-release bupropion (HCl) 300-450 mg/day and placebo administered for eight weeks for the treatment of adult outpatients with major depressive disorder including symptoms of decreased energy, pleasure, and interest

Study Type

Interventional

Enrollment

268

Phase

  • Phase 3

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
    • California
      • Beverly Hills, California, United States, 90210
        • GSK Investigational Site
      • Sherman Oaks, California, United States, 91403
        • GSK Investigational Site
      • Temecula, California, United States, 92591
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80212
        • GSK Investigational Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • GSK Investigational Site
      • Hamden, Connecticut, United States, 06518
        • GSK Investigational Site
      • Middletown, Connecticut, United States, 06457
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33156
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • GSK Investigational Site
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • GSK Investigational Site
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401
        • GSK Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • GSK Investigational Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • GSK Investigational Site
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • GSK Investigational Site
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • GSK Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97201
        • GSK Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865-4208
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78746
        • GSK Investigational Site
      • Dallas, Texas, United States, 75231
        • GSK Investigational Site
      • Houston, Texas, United States, 77004
        • GSK Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Primary diagnosis of MDD with current duration lasting 12 weeks but no greater than 2 years.
  • Generally in good health.
  • Subject must read and write at a level sufficient to provide written informed consent.

Exclusion criteria:

  • Current or past history of seizure disorder.
  • Subject has a primary diagnosis or received treatment for panic disorder, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), acute stress disorder, Bipolar I or II disorder, schizophrenia, or other psychotic disorder.
  • Currently using illicit drugs or other psychotropic drugs.
  • Patient poses a current suicidal risk or has attempted suicide in the past 6 months.

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.

Secondary Outcome Measures

Outcome Measure
Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2003

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

July 8, 2003

First Submitted That Met QC Criteria

July 9, 2003

First Posted (Estimate)

July 10, 2003

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK130931

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.

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