Wellbutrin XL, Major Depressive Disorder and Breast Cancer

April 16, 2007 updated by: Thomas Jefferson University

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

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Rajnish Mago, MD, Thomas Jefferson University Department of Psychiatry and Human Behavior

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (Estimate)

October 6, 2005

Study Record Updates

Last Update Posted (Estimate)

April 17, 2007

Last Update Submitted That Met QC Criteria

April 16, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot105042
  • 29000-J08101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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