Wellbutrin XL, Major Depressive Disorder and Breast Cancer

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborator: GlaxoSmithKline
• Treatments: Bupropion

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