Skip to main content
OpenTrials
Completed

NCT Number: NCT00064467

Lethargic Depression Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Consciousness Disorders Depression Depressive Disorder Depressive Disorder, Major Major Depressive Disorder (MDD) Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stupor Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Beverly Hills, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extended-release bupropion (HCl)

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jul 10, 2003
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.