Wellbutrin XL, Major Depressive Disorder and Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00234195
First received: October 4, 2005
Last updated: April 16, 2007
Last verified: April 2007
  Purpose
  • 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

Condition Intervention Phase
Breast Cancer
Major Depressive Disorder
Drug: bupropion extended release (Wellbutrin XL)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

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.

Estimated Enrollment: 25
Study Start Date: September 2005
Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00234195

Locations
United States, Pennsylvania
Thomas Jefferson University, Department of Psychiatry
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
GlaxoSmithKline
Investigators
Principal Investigator: Rajnish Mago, MD Thomas Jefferson University Department of Psychiatry and Human Behavior
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234195     History of Changes
Other Study ID Numbers: Prot105042, 29000-J08101
Study First Received: October 4, 2005
Last Updated: April 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Breast Cancer
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Breast Neoplasms
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
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 September 16, 2014