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Lethargic Depression Study

Primary Purpose

Epilepsy, Major Depressive Disorder (MDD)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Extended-release bupropion (HCl)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring lethargic, decreased interest, decreased motivation, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2003
Last Updated
May 24, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00064467
Brief Title
Lethargic Depression Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Major Depressive Disorder (MDD)
Keywords
lethargic, decreased interest, decreased motivation, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
268 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Extended-release bupropion (HCl)
Primary Outcome Measure Information:
Title
Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.
Secondary Outcome Measure Information:
Title
Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
GSK Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
GSK Investigational Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
Facility Name
GSK Investigational Site
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
GSK Investigational Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
GSK Investigational Site
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
GSK Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
GSK Investigational Site
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
GSK Investigational Site
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52401
Country
United States
Facility Name
GSK Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
GSK Investigational Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
GSK Investigational Site
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
GSK Investigational Site
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
GSK Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
GSK Investigational Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
GSK Investigational Site
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865-4208
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
GSK Investigational Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Rush J, VanMeter SA, Wightman D, Hampton KD, Krishen A, Modell JG. Wellbutrin XL for the treatment of adults with major depressive disorder. American Psychiatric Association 158th Annual Meeting, Atlanta, GA, 21-26 May, 2005, Abstract No. 787.
Results Reference
result
PubMed Identifier
16848645
Citation
Jefferson JW, Rush AJ, Nelson JC, VanMeter SA, Krishen A, Hampton KD, Wightman DS, Modell JG. Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2006 Jun;67(6):865-73. doi: 10.4088/jcp.v67n0602.
Results Reference
result
Citation
Rush J, VanMeter SA, Wightman DS, Hampton KD, Krishen A, Modell JG. Bupropion XL for the treatment of adults with major depressive disorder. 45th Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting, Boca Raton, FL, 6-9June, 2005.
Results Reference
result

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Lethargic Depression Study

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