Wellbutrin XL, Major Depressive Disorder and Breast Cancer - Full Text View

Sponsors and Collaborators:	Thomas Jefferson University GlaxoSmithKline
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00234195

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 IV

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Depression

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

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

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

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

Keywords provided by Thomas Jefferson University:

Breast Cancer
Major Depressive Disorder

Study placed in the following topic categories:

Dopamine
Depression
Skin Diseases
Mental Disorders
Bupropion
Mood Disorders

Breast Neoplasms
Depressive Disorder, Major
Depressive Disorder
Breast Diseases
Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009