Wellbutrin XL, Major Depressive Disorder and Breast Cancer

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234195

Enrollment

Registered

2005-10-06

Start date

2005-09-30

Completion date

2007-01-31

Last updated

2007-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Major Depressive Disorder

Keywords

Breast Cancer, Major Depressive Disorder

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.

Interventions

DRUGbupropion extended release (Wellbutrin XL)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026