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Post-marketing Carcinogenicity Study of Bupropion


N/A
18 Years
N/A
Not Enrolling
Both
Depressive Disorder, Cancer

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Trial Information

Post-marketing Carcinogenicity Study of Bupropion


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant

Outcome Description:

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.

Outcome Time Frame:

January 1, 1996 - December 31, 2006

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United Kingdom: No Health Authority

Study ID:

111982

NCT ID:

NCT01077596

Start Date:

June 2008

Completion Date:

March 2010

Related Keywords:

  • Depressive Disorder
  • Cancer
  • Carcinogenicity
  • Case control
  • Bupropion
  • Depressive Disorder
  • Depression

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