Carcinogenicity Study of Bupropion

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01077596
First received: February 25, 2010
Last updated: June 2, 2011
Last verified: June 2011

February 25, 2010
June 2, 2011
June 2008
March 2010   (final data collection date for primary outcome measure)
Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant [ Time Frame: January 1, 1996 - December 31, 2006 ] [ Designated as safety issue: Yes ]
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.
Risk of cancer (prostate, breast, lung, colon/rectum, urinary bladder, and uterus combined) in patients exposed to bupropion compared with the risk of cancer in patients exposed to all other antidepressants combined [ Time Frame: Date of diagnosis will be collected for each cancer case and the date of diagnosis serve as the index date (i.e., the point of reference from which exposure and confounding data are measured). ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01077596 on ClinicalTrials.gov Archive Site
  • Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant [ Time Frame: January 1, 1996 - December 31, 2006 ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant [ Time Frame: January 1, 1996 - December 31, 2006 ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant [ Time Frame: January 1, 1996 - December 31, 2006 ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant [ Time Frame: January 1, 1996 - December 31, 2006 ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant [ Time Frame: January 1, 1996 - December 31, 2006 ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant [ Time Frame: January 1, 1996 - December 31, 2006 ] [ Designated as safety issue: Yes ]
    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.
  • Risk of prostate, breast, lung, colon/rectum, urinary bladder & uterus cancer combined in patients exposed to bupropion compared w/(a) patients exposed to TCA class, (b) patients exposed to SSRI class and (c) patients exposed to all other antidepressants [ Time Frame: Date of diagnosis will be collected for each cancer case and the date of diagnosis serve as the index date (i.e., the point of reference from which exposure and confounding data are measured). ] [ Designated as safety issue: Yes ]
  • Risk of each cancer (prostate, breast, lung, colon/rectum, urinary bladder, and uterus ) in patients exposed to bupropion compared with the risk of cancer in patients exposed to all other antidepressants. [ Time Frame: Date of diagnosis will be collected for each cancer case and the date of diagnosis serve as the index date (i.e., the point of reference from which exposure and confounding data are measured). ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Carcinogenicity Study of Bupropion
Post-marketing Carcinogenicity Study of Bupropion

There is a lack of toxicology data on one bupropion metabolite, and limited literature examining bupropion use and cancer risk. This study evaluates the association between bupropion exposure and the development of cancer of the prostate, breast, lung, colon/rectum, urinary bladder, and uterus by comparing the risk of cancer in bupropion users with other antidepressant users. Because there is no evidence that bupropion is associated with any particular cancer, we have chosen the six most common cancers diagnosed in the United States to optimize statistical power/precision for cancer-site specific comparisons. Two US population-based data resources with automated claims, pharmacy, and tumor registry data are included in this study. Using a nested case-control design, this study will compare the incidence of cancer in patients exposed to bupropion with the incidence in patients exposed to other antidepressants.

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

New users of antidepressants January 1, 1996 through December 31, 2006, regardless of indication for use (depression, smoking cessation, other) in Henry Ford Health System and Kaiser Permanente Health Plan of Northern California. The study population is limited to individuals 18 years of age or older with medical and pharmacy benefits and at least 6 months of health plan enrollment before the first antidepressant prescription. Patients with a history of any cancer (cancer diagnosis recorded in the tumor registries anytime before the first antidepressant prescription recorded during the study period) are excluded. Cases and controls will be selected from this cohort of antidepressant-exposed study subjects.

  • Depressive Disorder
  • Cancer
  • Drug: Regular bupropion use
    Regular use of bupropion is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.
  • Drug: Regular SSRI (Selective serotonin reuptake inhibitors) use
    Regular use of SSRI is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.
  • Drug: Regular TCA (Tricyclic antidepressants) use
    Regular use of TCA is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.
  • Drug: Regular use of any other antidepressant
    Regular use of any other antidepressants is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date. An "other antidepressant" would be any antidepressant other than bupropion, a SSRI or a TCA.
New users of antidepressants Jan. 1, 1996 to Dec. 31, 2006
All new users of antidepressants January 1, 1996 through December 31, 2006. Individuals 18 years of age or older with medical and pharmacy benefits and at least 6 months of health plan enrollment before the first antidepressant prescription.
Interventions:
  • Drug: Regular bupropion use
  • Drug: Regular SSRI (Selective serotonin reuptake inhibitors) use
  • Drug: Regular TCA (Tricyclic antidepressants) use
  • Drug: Regular use of any other antidepressant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50430
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

-

Exclusion Criteria:

  • Cancers diagnosed within 12 months of initiation (i.e., new use) of antidepressant pharmacotherapy will be excluded to account for a minimum period for the development of cancer (cancer latency) and to be consistent with other studies of antidepressants and cancer.
  • Patients with a history of any cancer (cancer diagnosis recorded in the tumor registries anytime before the first antidepressant prescription recorded during the study period)
  • Any antidepressant use within 6 months of January 1, 1996
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01077596
111982, EPI40463, WEUKSTV1113
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP