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Wellbutrin XL for Dysthymic Disorder

Primary Purpose

Dysthymic Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bupropion XL
Placebo
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysthymic Disorder focused on measuring Dysthymic Disorder, Dysthymia, Depression, Chronic Depression, Wellbutrin XL

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bupropion XL

Placebo

Arm Description

Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale, 24 Items (HDRS)
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)

Secondary Outcome Measures

Cornell Dysthymia Rating Scale (CDRS)
A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression
Beck Depression Inventory (BDI)
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)
A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
Global Assessment of Functioning Scale (GAFS)
A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)

Full Information

First Posted
September 21, 2005
Last Updated
October 29, 2015
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00225251
Brief Title
Wellbutrin XL for Dysthymic Disorder
Official Title
Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysthymic Disorder
Keywords
Dysthymic Disorder, Dysthymia, Depression, Chronic Depression, Wellbutrin XL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bupropion XL
Arm Type
Experimental
Arm Description
Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
Intervention Type
Drug
Intervention Name(s)
bupropion XL
Other Intervention Name(s)
Wellbutrin XL
Intervention Description
Antidepressant medication
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale, 24 Items (HDRS)
Description
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)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Cornell Dysthymia Rating Scale (CDRS)
Description
A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression
Time Frame
10 weeks
Title
Beck Depression Inventory (BDI)
Description
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.
Time Frame
10 weeks
Title
Clinical Global Improvement (CGI)
Description
A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
Time Frame
10 weeks
Title
Global Assessment of Functioning Scale (GAFS)
Description
A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Hellerstein, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11386496
Citation
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. doi: 10.1097/00004714-200106000-00012.
Results Reference
background
Links:
URL
http://www.DepressionNY.com
Description
For more information about our program or this study, click here.

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Wellbutrin XL for Dysthymic Disorder

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