Status:
COMPLETED
Wellbutrin XL, Major Depressive Disorder and Breast Cancer
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Breast Cancer
Major Depressive Disorder
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 extende...
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 functio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00234195
Start Date
September 1 2005
End Date
January 1 2007
Last Update
April 17 2007
Active Locations (1)
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1
Thomas Jefferson University, Department of Psychiatry
Philadelphia, Pennsylvania, United States, 19107