Clinical trial NCT00064467: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Major Depressive Disorder (MDD)
Keywords: lethargic
decreased interest
decreased motivation
depression
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-07-10
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.
Secondary outcomes:
measure: Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: GSK Investigational Site
state: California
city: Temecula
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Cromwell
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Hamden
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Middletown
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Marietta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Oak Brook
country: United States
facility: GSK Investigational Site
state: Illinois
city: Cedar Rapids
country: United States
facility: GSK Investigational Site
state: Iowa
city: Rockville
country: United States
facility: GSK Investigational Site
state: Maryland
city: Farmington Hills
country: United States
facility: GSK Investigational Site
state: Michigan
city: Ridgeland
country: United States
facility: GSK Investigational Site
state: Mississippi
city: Moorestown
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Beachwood
country: United States
facility: GSK Investigational Site
state: Ohio
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.