Clinical trial · Interventional
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
NCT00234195CI-TRIAL-00000676completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Major Depressive Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bupropion extended release (Wellbutrin XL) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment of Major Depressive Disorder in women with breast cancer.
- measure
- To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these patients
Secondary outcomes (1)
- measure
- To evaluate the effect of bupropion extended-release (Wellbutrin XL™) on fatigue, sexual functioning, and pain in these patients.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDVita G, Compri B, Matcham F, Barbui C, Ostuzzi G. Antidepressants for the treatment of depression in people with cancer. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD011006. doi: 10.1002/14651858.CD011006.pub4. PMID 36999619