Spots Global Cancer Trial Database for Carcinogenicity Study of Bupropion

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Trial Identification

Brief Title: Carcinogenicity Study of Bupropion

Official Title: Post-marketing Carcinogenicity Study of Bupropion

Study ID: NCT01077596

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

Study Description

Brief Summary: 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.

Detailed Description: 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.