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Lethargic Depression Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00064467
First received: July 8, 2003
Last updated: May 24, 2017
Last verified: May 2017
July 8, 2003
May 24, 2017
June 2003
May 2005   (Final data collection date for primary outcome measure)
Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.
Not Provided
Complete list of historical versions of study NCT00064467 on ClinicalTrials.gov Archive Site
Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.
Not Provided
Not Provided
Not Provided
 
Lethargic Depression Study
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.
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
  • Epilepsy
  • Major Depressive Disorder (MDD)
Drug: Extended-release bupropion (HCl)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
May 2005
May 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00064467
AK130931
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP