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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00064467

Enrollment

268

Registered

2003-07-10

Start date

2003-06-30

Completion date

2005-05-31

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Major Depressive Disorder (MDD)

Keywords

lethargic, decreased interest, decreased motivation, depression

Brief summary

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

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

Interventions

DRUGExtended-release bupropion (HCl)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026