Lethargic Depression Study

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Major Depressive Disorder (MDD)

Treatments

Drug: Extended-release bupropion (HCl)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00064467

AK130931

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.