Lethargic Depression Study - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00064467

Purpose

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

Condition	Intervention	Phase
Major Depressive Disorder (MDD)	Drug: Extended-release bupropion (HCl)	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment:	268
Study Start Date:	June 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064467

Show 24 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	AK130931
Study First Received:	July 8, 2003
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00064467
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

lethargic
depression
decreased interest
decreased motivation

Study placed in the following topic categories:

Dopamine
Depression
Mental Disorders
Bupropion

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009