Lethargic Depression Study

GlaxoSmithKline268 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

268

Conditions

Epilepsy Major Depressive Disorder (MDD)

Interventions

Extended-release bupropion (HCl)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

GSK Investigational Site

Beverly Hills, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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