ClinicalTrials.gg
CompletedNCT00064467Updated May 30, 2017

Lethargic Depression Study

A Phase 3 interventional study of Extended-release bupropion (HCl) in Epilepsy and Major Depressive Disorder (MDD), sponsored by GlaxoSmithKline. Completed at 24 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
268
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 54 studies in Epilepsy by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. Epilepsy · GlaxoSmithKline.

Enrollment
4th of 39
268 · median 76
Started
2003
with 1 other
Phase 3
18 of 54
none open now
Registered
5th of 54
by date

Among the 54 studies in Epilepsy by GlaxoSmithKline, this one is the 4th largest by enrollment of the 39 interventional ones that give a count, is one of 2 that started in 2003, is one of 18 in phase 3, and was the 5th registered.

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 419 are open to participants now.

Browse Epilepsy studies →

Open to participants now

None of the 54 studies in Epilepsy by GlaxoSmithKline is open now. The open studies under Epilepsy, anywhere →

Who these studies take

Of the 282 Epilepsy studies recruiting now, 112 (40%) set no upper age limit and 147 (52%) stop at 75 or younger; 139 take children under 18; 55 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 54 studies in Epilepsy by GlaxoSmithKline as a file.
02

Study summary

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

Read the 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

03

Conditions studied

  • Epilepsy
  • Major Depressive Disorder (MDD)

Keywords

  • lethargic
  • decreased interest
  • decreased motivation
  • depression
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
268 participants

Interventions

  • DrugExtended-release bupropion (HCl)
06

What researchers measure

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.

07

Study locations

24 sites
  • GSK Investigational Site
    Beverly Hills, California 90210, United States
  • GSK Investigational Site
    Sherman Oaks, California 91403, United States
  • GSK Investigational Site
    Temecula, California 92591, United States
  • GSK Investigational Site
    Denver, Colorado 80212, United States
  • GSK Investigational Site
    Cromwell, Connecticut 06416, United States
  • GSK Investigational Site
    Hamden, Connecticut 06518, United States
  • GSK Investigational Site
    Middletown, Connecticut 06457, United States
  • GSK Investigational Site
    Miami, Florida 33156, United States
  • GSK Investigational Site
    Marietta, Georgia 30060, United States
  • GSK Investigational Site
    Oak Brook, Illinois 60523, United States
  • GSK Investigational Site
    Cedar Rapids, Iowa 52401, United States
  • GSK Investigational Site
    Rockville, Maryland 20852, United States
  • GSK Investigational Site
    Farmington Hills, Michigan 48336, United States
  • GSK Investigational Site
    Ridgeland, Mississippi 39157, United States
  • GSK Investigational Site
    Moorestown, New Jersey 08057, United States
  • GSK Investigational Site
    Albuquerque, New Mexico 87108, United States
  • GSK Investigational Site
    Beachwood, Ohio 44122, United States
  • GSK Investigational Site
    Portland, Oregon 97201, United States
  • GSK Investigational Site
    Lincoln, Rhode Island 02865-4208, United States
  • GSK Investigational Site
    Austin, Texas 78746, United States
  • GSK Investigational Site
    Dallas, Texas 75231, United States
  • GSK Investigational Site
    Houston, Texas 77004, United States
  • GSK Investigational Site
    Lake Jackson, Texas 77566, United States
  • GSK Investigational Site
    San Antonio, Texas 78229, United States
08

References and documents

Publications

  • Rush J, VanMeter SA, Wightman D, Hampton KD, Krishen A, Modell JG. Wellbutrin XL for the treatment of adults with major depressive disorder. American Psychiatric Association 158th Annual Meeting, Atlanta, GA, 21-26 May, 2005, Abstract No. 787.
  • Jefferson JW, Rush AJ, Nelson JC, VanMeter SA, Krishen A, Hampton KD, Wightman DS, Modell JG. Extended-release bupropion for patients with major depressive disorder presenting with symptoms of reduced energy, pleasure, and interest: findings from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2006 Jun;67(6):865-73. doi: 10.4088/jcp.v67n0602. PubMed 16848645 ↗
  • Rush J, VanMeter SA, Wightman DS, Hampton KD, Krishen A, Modell JG. Bupropion XL for the treatment of adults with major depressive disorder. 45th Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting, Boca Raton, FL, 6-9June, 2005.
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2003, a primary completion of May 2005 and a completion of May 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2003
First posted
Jul 10, 2003
Start
Jun 2003
Primary completionActual
May 2005
CompletionActual
May 2005
Last update
May 30, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00064467
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 10, 2003
Start date
Jun 2003
Primary completion
May 2005
Completion
May 2005
Last update
May 30, 2017

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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