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Wellbutrin XL for Dysthymic Disorder

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ClinicalTrials.gov Identifier: NCT00225251
Recruitment Status : Completed
First Posted : September 23, 2005
Results First Posted : November 24, 2014
Last Update Posted : November 26, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Tracking Information
First Submitted Date  ICMJE September 21, 2005
First Posted Date  ICMJE September 23, 2005
Results First Submitted Date  ICMJE May 13, 2014
Results First Posted Date  ICMJE November 24, 2014
Last Update Posted Date November 26, 2015
Study Start Date  ICMJE November 2004
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2014)
Hamilton Depression Rating Scale, 24 Items (HDRS) [ Time Frame: 10 weeks ]
Widely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue. This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
Hamilton Depression Rating Scale, 24 Items (HDRS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2014)
  • Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 10 weeks ]
    A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression
  • Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ]
    21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
  • Clinical Global Improvement (CGI) [ Time Frame: 10 weeks ]
    A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
  • Global Assessment of Functioning Scale (GAFS) [ Time Frame: 10 weeks ]
    A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
  • Cornell Dysthymia Rating Scale (CDRS)
  • Beck Depression Inventory (BDI)
  • Clinical Global Impressions (CGI)
  • Global Assessment of Functioning Scale (GAFS)
  • Patient-CGI (CGI-P)
  • Social Adjustment Scale (SAS)
  • Symptom Checklist (SCL-90-R)
  • Temperament and Character Inventory (TCI)
  • Medical Outcomes Study- HIV - Cognitive Scale (MOS-HIVcs)
  • Aldenkamp-Baker Neurotoxicity Scale (ABS)
  • Arizona Sexual Experiences Scale (ASEX)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Wellbutrin XL for Dysthymic Disorder
Official Title  ICMJE Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL
Brief Summary 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.
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 Diagnostic and Statistical Manual-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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dysthymic Disorder
Intervention  ICMJE
  • Drug: bupropion XL
    Antidepressant medication
    Other Name: Wellbutrin XL
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: bupropion XL
    Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
    Intervention: Drug: bupropion XL
  • Placebo Comparator: Placebo
    Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
    Intervention: Other: Placebo
Publications * Hellerstein DJ, Batchelder S, Kreditor D, Fedak M. Bupropion sustained-release for the treatment of dysthymic disorder: an open-label study. J Clin Psychopharmacol. 2001 Jun;21(3):325-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2013)
18
Original Enrollment  ICMJE
 (submitted: September 21, 2005)
60
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female outpatients 18-65 years of age.
  • Patients with a Diagnostic and Statistical Manual Fourth Edition (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00225251
Other Study ID Numbers  ICMJE gsk 102149
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Luke's-Roosevelt Hospital Center
Study Sponsor  ICMJE St. Luke's-Roosevelt Hospital Center
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: David J. Hellerstein, MD St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute
PRS Account St. Luke's-Roosevelt Hospital Center
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP