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Wellbutrin XL, Major Depressive Disorder and Breast Cancer

Primary Purpose

Breast Cancer, Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bupropion extended release (Wellbutrin XL)
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women aged 18 years or older Diagnosis of breast cancer, confirmed by histopathology; Stages 0, I, II, IIIA, or IIIB Clinical diagnosis of Major Depressive Disorder (DSM-IV-TR) Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983) depression subscale score of 11 or greater Montgomery Asberg Depression Rating Scale (MADRS; Montgomery and Asberg, 1979) score of 25 or greater at Screening and Baseline visits Use of antidepressants in a previous episode of major depression or in the past for any other indication does not affect the patient's inclusion in this study. During the current episode of major depressive disorder, as stated in the Exclusion criteria, failure to respond to one or more adequate trials of an antidepressant will exclude the patient from the study since this is not a study of "treatment-resistant depression". During the study, the patient may not use any other antidepressants. Exclusion Criteria: Presence of another current clinically significant Axis I disorder like bipolar disorder, schizophrenia, or panic disorder Current (in past 6 months) comorbid active substance abuse or dependence Failure to respond to one or more adequate trials of an antidepressant in the current episode of MDD A reduction in MADRS score of 20% or greater from Screening to Baseline visit Clinically significant laboratory abnormalities that in the judgment of the Investigator would increase risk of adverse effects with bupropion Pregnant or lactating women History of an eating disorder, seizures, head injury, or other intracranial pathology because these conditions are usually contraindications to the use of bupropion XL Previous allergy or intolerance to bupropion Patients judged to be at significant suicidal risk

Sites / Locations

  • Thomas Jefferson University, Department of Psychiatry

Outcomes

Primary Outcome Measures

To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment of Major Depressive Disorder in women with breast cancer.
To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these patients

Secondary Outcome Measures

To evaluate the effect of bupropion extended-release (Wellbutrin XL™) on fatigue, sexual functioning, and pain in these patients.

Full Information

First Posted
October 4, 2005
Last Updated
April 16, 2007
Sponsor
Thomas Jefferson University
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00234195
Brief Title
Wellbutrin XL, Major Depressive Disorder and Breast Cancer
Official Title
A Pilot Study of the Efficacy and Tolerability of Bupropion Extended Release (Wellbutrin XL) for the Treatment of Major Depressive Disorder in Women With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Thomas Jefferson University
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment of Major Depressive Disorder in women with breast cancer. To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these patients
Detailed Description
This is research study for women diagnosed with breast cancer and major depression. Women with breast cancer who are depressed may report greater pain, poorer quality of life and worse overall functioning than those without depression. The study will determine whether or not bupropion extended release (Wellbutrin XLTM) is useful in lessening the symptoms of depression in women with breast cancer. One reason for conducting this research with bupropion extended release (Wellbutrin XLTM) instead of another antidepressant is because bupropion has a lower likelihood of causing the side effects of weight gain, sexual dysfunction, and fatigue, which may be important for women with breast cancer and may even have a beneficial effect on these symptoms. Bupropion extended release (Wellbutrin XL™)is approved by the United States Food and Drug Administration (FDA) for the treatment of major depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Major Depressive Disorder
Keywords
Breast Cancer, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bupropion extended release (Wellbutrin XL)
Primary Outcome Measure Information:
Title
To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment of Major Depressive Disorder in women with breast cancer.
Title
To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these patients
Secondary Outcome Measure Information:
Title
To evaluate the effect of bupropion extended-release (Wellbutrin XL™) on fatigue, sexual functioning, and pain in these patients.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women aged 18 years or older Diagnosis of breast cancer, confirmed by histopathology; Stages 0, I, II, IIIA, or IIIB Clinical diagnosis of Major Depressive Disorder (DSM-IV-TR) Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983) depression subscale score of 11 or greater Montgomery Asberg Depression Rating Scale (MADRS; Montgomery and Asberg, 1979) score of 25 or greater at Screening and Baseline visits Use of antidepressants in a previous episode of major depression or in the past for any other indication does not affect the patient's inclusion in this study. During the current episode of major depressive disorder, as stated in the Exclusion criteria, failure to respond to one or more adequate trials of an antidepressant will exclude the patient from the study since this is not a study of "treatment-resistant depression". During the study, the patient may not use any other antidepressants. Exclusion Criteria: Presence of another current clinically significant Axis I disorder like bipolar disorder, schizophrenia, or panic disorder Current (in past 6 months) comorbid active substance abuse or dependence Failure to respond to one or more adequate trials of an antidepressant in the current episode of MDD A reduction in MADRS score of 20% or greater from Screening to Baseline visit Clinically significant laboratory abnormalities that in the judgment of the Investigator would increase risk of adverse effects with bupropion Pregnant or lactating women History of an eating disorder, seizures, head injury, or other intracranial pathology because these conditions are usually contraindications to the use of bupropion XL Previous allergy or intolerance to bupropion Patients judged to be at significant suicidal risk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajnish Mago, MD
Organizational Affiliation
Thomas Jefferson University Department of Psychiatry and Human Behavior
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University, Department of Psychiatry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Wellbutrin XL, Major Depressive Disorder and Breast Cancer

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