Lethargic Depression Study

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064467
• Other study ID #: AK130931
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2003
• Last updated: May 24, 2017
• Start date: June 2003
• Est. completion date: May 2005

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Epilepsy
• Lethargy
• Major Depressive Disorder (MDD)

Intervention

Drug:
• Extended-release bupropion (HCl)

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Beachwood	Ohio
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Cedar Rapids	Iowa
United States	GSK Investigational Site	Cromwell	Connecticut
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Farmington Hills	Michigan
United States	GSK Investigational Site	Hamden	Connecticut
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Lake Jackson	Texas
United States	GSK Investigational Site	Lincoln	Rhode Island
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Middletown	Connecticut
United States	GSK Investigational Site	Moorestown	New Jersey
United States	GSK Investigational Site	Oak Brook	Illinois
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Ridgeland	Mississippi
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Sherman Oaks	California
United States	GSK Investigational Site	Temecula	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 random — View 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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.
Secondary	Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.