Lethargic Depression Study

NCT ID: NCT00064467

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-05-31

Brief Summary

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

Detailed Description

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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

Conditions

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Epilepsy Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Extended-release bupropion (HCl)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Beverly Hills, California, United States

Site Status

GSK Investigational Site

Sherman Oaks, California, United States

Site Status

GSK Investigational Site

Temecula, California, United States

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GSK Investigational Site

Denver, Colorado, United States

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GSK Investigational Site

Cromwell, Connecticut, United States

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GSK Investigational Site

Hamden, Connecticut, United States

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GSK Investigational Site

Middletown, Connecticut, United States

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GSK Investigational Site

Miami, Florida, United States

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GSK Investigational Site

Marietta, Georgia, United States

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GSK Investigational Site

Oak Brook, Illinois, United States

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GSK Investigational Site

Cedar Rapids, Iowa, United States

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GSK Investigational Site

Rockville, Maryland, United States

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GSK Investigational Site

Farmington Hills, Michigan, United States

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GSK Investigational Site

Ridgeland, Mississippi, United States

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GSK Investigational Site

Moorestown, New Jersey, United States

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GSK Investigational Site

Albuquerque, New Mexico, United States

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GSK Investigational Site

Beachwood, Ohio, United States

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GSK Investigational Site

Portland, Oregon, United States

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GSK Investigational Site

Lincoln, Rhode Island, United States

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GSK Investigational Site

Austin, Texas, United States

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GSK Investigational Site

Dallas, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Lake Jackson, Texas, United States

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GSK Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 16848645 (View on PubMed)

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.

Reference Type RESULT

Other Identifiers

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AK130931

Identifier Type: -

Identifier Source: org_study_id

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