Wellbutrin XL for Dysthymic Disorder

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00225251
First received: September 21, 2005
Last updated: February 26, 2013
Last verified: January 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
    Widely used depression rating scale, with range of scores from 0 to 90, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue.


Secondary Outcome Measures:
  • Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Self rated scale rated by patients for depression symptoms

  • Clinical Global Improvement (CGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)


Enrollment: 18
Study Start Date: November 2004
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bupropion XL
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
Drug: bupropion XL
Antidepressant medication
Other Name: Wellbutrin XL
Placebo Comparator: Placebo
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00225251     History of Changes
Other Study ID Numbers: gsk 102149
Study First Received: September 21, 2005
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dysthymic Disorder
Depressive Disorder
Mood Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014