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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


Phase 4
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Major Depressive Disorder

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment of Major Depressive Disorder in women with breast cancer.

Principal Investigator

Rajnish Mago, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University Department of Psychiatry and Human Behavior

Authority:

United States: Food and Drug Administration

Study ID:

Prot105042

NCT ID:

NCT00234195

Start Date:

September 2005

Completion Date:

January 2007

Related Keywords:

  • Breast Cancer
  • Major Depressive Disorder
  • Breast Cancer
  • Major Depressive Disorder
  • Breast Neoplasms
  • Depressive Disorder
  • Depression
  • Depressive Disorder, Major

Name

Location

Thomas Jefferson University, Department of PsychiatryPhiladelphia, Pennsylvania  19107