Breast CancerPhase 4NCT00234195
Wellbutrin XL, Major Depressive Disorder and Breast Cancer
A Phase 4 study testing bupropion extended release (Wellbutrin XL) in people with Breast Cancer and Major Depressive Disorder, run by Thomas Jefferson University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Major Depressive Disorder
- What is being tested?
- bupropion extended release (Wellbutrin XL)
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University, Department of Psychiatry
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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
- 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
Read the 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.
- Conditions
- Breast Cancer, Major Depressive Disorder
- Being tested
- bupropion extended release (Wellbutrin XL)
- Keywords
- Breast Cancer, Major Depressive Disorder
- Medical subject headings
- Breast Neoplasms, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion extended release (Wellbutrin XL)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
To evaluate the effect of bupropion extended-release (Wellbutrin XL™) on fatigue, sexual functioning, and pain in these patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startSep 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Rajnish Mago, MD, Principal investigator, Thomas Jefferson University Department of Psychiatry and Human Behavior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234195
- Sponsor's protocol ID
- Prot105042
- Other IDs
- 29000-J08101
- Status last verified
- Apr 2007
- First submitted
- 4 Oct 2005
- Last updated
- 17 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Vita 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.
PubMed 36999619
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00234195
- Acronym / sponsor ID
- Prot105042
- Conditions
- Breast Cancer, Major Depressive Disorder
- Keywords
- Breast Cancer, Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 6 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropion extended release (Wellbutrin XL) | Drug | – |
Primary outcome
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
1 secondary outcome
To evaluate the effect of bupropion extended-release (Wellbutrin XL™) on fatigue, sexual functioning, and pain in these patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2007.
- Derived from this study: PubMed 36999619Vita 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajnish Mago, MD principal investigator
Thomas Jefferson University Department of Psychiatry and Human Behavior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupropion extended release (Wellbutrin XL) in people with Breast Cancer and Major Depressive Disorder, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment of Major Depressive Disorder in women with breast cancer.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00234195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2007.