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Wellbutrin XL for Dysthymic Disorder

This study has been completed.

Sponsors and Collaborators: St. Luke's-Roosevelt Hospital Center
GlaxoSmithKline
Information provided by: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00225251
  Purpose

This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.


Condition Intervention Phase
Dysthymic Disorder
Drug: bupropion XL
Phase IV

MedlinePlus related topics:   Depression   

Drug Information available for:   Bupropion hydrochloride    Bupropion   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale, 24 items (HDRS) [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 10 weeks ]
  • Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ]
  • Clinical Global Impressions (CGI) [ Time Frame: 10 weeks ]
  • Global Assessment of Functioning Scale (GAFS) [ Time Frame: 10 weeks ]
  • Patient-CGI (CGI-P) [ Time Frame: 10 weeks ]
  • Social Adjustment Scale (SAS) [ Time Frame: 10 weeks ]
  • Symptom Checklist (SCL-90-R) [ Time Frame: 10 weeks ]
  • Temperament and Character Inventory (TCI) [ Time Frame: 10 weeks ]
  • Medical Outcomes Study- HIV – Cognitive Scale (MOS-HIVcs) [ Time Frame: 10 weeks ]
  • Aldenkamp-Baker Neurotoxicity Scale (ABS) [ Time Frame: 10 weeks ]
  • Arizona Sexual Experiences Scale (ASEX) [ Time Frame: 10 weeks ]

Estimated Enrollment:   60
Study Start Date:   November 2004

Detailed Description:

This is a ten-week, double-blind, placebo-controlled study designed to evaluate the tolerability, dosing and efficacy of Wellbutrin XL in outpatients who meet DSM-IV criteria for early onset, primary type dysthymic disorder (low-grade chronic depression). It is hypothesized that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Male and female outpatients 18-65 years of age.
  • Patients with a DSM-IV diagnosis of dysthymic disorder, early onset.
  • Patients will have a total score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.

Exclusion Criteria:

  • Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.
  • Patients who are pregnant or nursing women.
  • Patients with a principal diagnosis meeting DSM-IV criteria for: Major Depressive disorder, Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder
  • Patients who have a current or prior diagnosis of Anorexia Nervosa or Bulimia
  • Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol.
  • Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:

    • Report of having a specific plan for killing themselves,
    • A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, (indicative of active suicidal thoughts or behaviors), or
    • A suicide attempt within the past 12 months requiring emergency room visit, medical or psychiatric hospitalization, or otherwise deemed to be life-threatening (e.g. an overdose of > 1 week’s dose of medication).
  • Patients with a history of recurrent Grand Mal seizures or at risk of Grand Mal seizures, and those with other medical conditions in which Wellbutrin XL would be contraindicated, including a history of head trauma.
  • Use of any psychotropic medication within 1 week of starting study medication
  • Use of a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) within the 14 days prior to the initial dose of study medication.
  • Use of fluoxetine within 28 days of the initial dose of study medication.
  • Use of Zyban® or other forms of bupropion hydrochloride (i.e. Wellbutrin immediate release or Wellbutrin Sustained Release (SR)) within 2 weeks of the initial dose of medication.
  • Patients who have failed to respond to adequate trials (minimum of six consecutive weeks) of two different classes of antidepressant medication (see Table 1 for definitions of an adequate trial.)
  • Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical illness, including any cardiovascular, hepatic, respiratory, hematological, endocrinologic or neurologic disease, or any clinically significant laboratory abnormality.
  • Patients who have begun a course of psychotherapy within 3 months of starting the study, or who plan to terminate an ongoing psychotherapy prior to the end of the study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225251

Locations
United States, New York
Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center    
      New York, New York, United States, 10019

Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
GlaxoSmithKline

Investigators
Principal Investigator:     David J. Hellerstein, MD     St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute    
  More Information


For more information about our program or this study, click here.  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   gsk 102149
First Received:   September 21, 2005
Last Updated:   June 5, 2007
ClinicalTrials.gov Identifier:   NCT00225251
Health Authority:   United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Dysthymic Disorder  
Dysthymia  
Depression  
Chronic Depression  
Wellbutrin XL  

Study placed in the following topic categories:
Dopamine
Depression
Mental Disorders
Bupropion
Mood Disorders
Dysthymic Disorder
Depressive Disorder

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 30, 2008




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