Trial · NCT01077596
Carcinogenicity Study of Bupropion
NCT01077596, Completed, GlaxoSmithKline; results first posted 2011-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Carcinogenicity Study of Bupropion. Trials, record NCT01077596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01077596
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carcinogenicity Study of Bupropion
- NCT number
- NCT01077596
- Status
- Completed
- Enrollment
- 50,430 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Depressive Disorder, Cancer
- Interventions
- Regular bupropion use, Regular SSRI (Selective serotonin reuptake inhibitors) use, Regular TCA (Tricyclic antidepressants) use, Regular use of any other antidepressant
- First posted
- 2010-03-01
- Last updated
- 2017-05-30
- Results first posted
- 2011-02-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | The following are the cancers under investigation: colorectal, lung, bladder, uterus, breast, and prostate. Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug. |
| Secondary | Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | In this outcome, colorectal cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Colorectal cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug. |
| Secondary | Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | In this outcome, lung cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Lung cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug. |
| Secondary | Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | In this outcome, bladder cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Bladder cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug. |
| Secondary | Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | In this outcome, uterine cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Uterine cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug. |
| Secondary | Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | In this outcome, breast cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Breast cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug. |
| Secondary | Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | In this outcome, prostate cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Prostate cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | Participants diagnosed with colorectal, lung, bladder, uterus, breast, or prostate cancer who were new antidepressant users | participants | NUMBER |
| SECONDARY | Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | Participants diagnosed with colorectal cancer who were new antidepressant users. | participants | NUMBER |
| SECONDARY | Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | Participants diagnosed with lung cancer who were new antidepressant users. | participants | NUMBER |
| SECONDARY | Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | Participants diagnosed with bladder cancer who were new antidepressant users. | participants | NUMBER |
| SECONDARY | Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | Participants diagnosed with uterine cancer who were new antidepressant users. | participants | NUMBER |
| SECONDARY | Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | Participants diagnosed with breast cancer who were new antidepressant users. | participants | NUMBER |
| SECONDARY | Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant | January 1, 1996 - December 31, 2006 | Participants diagnosed with prostate cancer who were new antidepressant users. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | Bupropion, Regular Use | Cases | 853 | participants | |
| Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | All Non-bupropion Antidepressants, Regular Use | Cases | 4561 | participants | |
| Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | Tricyclic Antidepressants (TCA), Regular Use | Cases | 1963 | participants | |
| Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use | Cases | 2570 | participants | |
| Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | Other Antidepressants, Regular Use | Cases | 1027 | participants | |
| Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | Bupropion, Regular Use | Controls | 6332 | participants | |
| Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | All Non-bupropion Antidepressants, Regular Use | Controls | 37831 | participants | |
| Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | Tricyclic Antidepressants (TCA), Regular Use | Controls | 16574 | participants | |
| Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use | Controls | 21170 | participants | |
| Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant | Other Antidepressants, Regular Use | Controls | 9096 | participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | New Antidepressant Exposure in Colorectal Cancer: Cases | 350 | |
| Overall Study | STARTED | New Antidepressant Exposure in Colorectal Cancer: Controls | 1,050 | |
| Overall Study | STARTED | New Antidepressant Exposure in Lung Cancer: Cases | 457 | |
| Overall Study | STARTED | New Antidepressant Exposure in Lung Cancer: Controls | 1,370 | |
| Overall Study | STARTED | New Antidepressant Exposure in Bladder Cancer: Cases | 294 | |
| Overall Study | STARTED | New Antidepressant Exposure in Bladder Cancer: Controls | 882 | |
| Overall Study | STARTED | Antidepressant Exposure in Uterine Cancer: Cases | 308 | |
| Overall Study | STARTED | New Antidepressant Exposure in Uterine Cancer: Controls | 837 | |
| Overall Study | STARTED | New Antidepressant Exposure in Breast Cancer: Cases | 2,842 | |
| Overall Study | STARTED | New Antidepressant Exposure in Breast Cancer: Controls | 28,420 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | New Antidepressant Exposure in Colorectal Cancer: Cases | ||
| Total, all-cause mortality | New Antidepressant Exposure in Colorectal Cancer: Controls | ||
| Total, all-cause mortality | New Antidepressant Exposure in Lung Cancer: Cases | ||
| Total, all-cause mortality | New Antidepressant Exposure in Lung Cancer: Controls | ||
| Total, all-cause mortality | New Antidepressant Exposure in Bladder Cancer: Cases | ||
| Total, all-cause mortality | New Antidepressant Exposure in Bladder Cancer: Controls | ||
| Total, all-cause mortality | New Antidepressant Exposure in Uterine Cancer: Cases | ||
| Total, all-cause mortality | New Antidepressant Exposure in Uterine Cancer: Controls | ||
| Total, all-cause mortality | New Antidepressant Exposure in Breast Cancer: Cases | ||
| Total, all-cause mortality | New Antidepressant Exposure in Breast Cancer: Controls |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01077596/results?page=2