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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00064467
Other study ID # AK130931
Secondary ID
Status Completed
Phase Phase 3
First received July 8, 2003
Last updated May 24, 2017
Start date June 2003
Est. completion date May 2005

Study information

Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 268
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Extended-release bupropion (HCl)


Locations

Country Name City State
United States GSK Investigational Site Albuquerque New Mexico
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Beachwood Ohio
United States GSK Investigational Site Beverly Hills California
United States GSK Investigational Site Cedar Rapids Iowa
United States GSK Investigational Site Cromwell Connecticut
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Denver Colorado
United States GSK Investigational Site Farmington Hills Michigan
United States GSK Investigational Site Hamden Connecticut
United States GSK Investigational Site Houston Texas
United States GSK Investigational Site Lake Jackson Texas
United States GSK Investigational Site Lincoln Rhode Island
United States GSK Investigational Site Marietta Georgia
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Middletown Connecticut
United States GSK Investigational Site Moorestown New Jersey
United States GSK Investigational Site Oak Brook Illinois
United States GSK Investigational Site Portland Oregon
United States GSK Investigational Site Ridgeland Mississippi
United States GSK Investigational Site Rockville Maryland
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site Sherman Oaks California
United States GSK Investigational Site Temecula California

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 random — View Citation

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.

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.
Secondary Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.
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