Carcinogenicity Study of Bupropion

NCT ID: NCT01077596

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50430 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-03-31

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.

Conditions

Depressive Disorder; Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Regular bupropion use

Intervention Type: DRUG

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.

Regular SSRI (Selective serotonin reuptake inhibitors) use

Intervention Type: DRUG

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.

Regular TCA (Tricyclic antidepressants) use

Intervention Type: DRUG

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.

Regular use of any other antidepressant

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

EPI40463

Identifier Type: -

Identifier Source: secondary_id

WEUKSTV1113

Identifier Type: -

Identifier Source: secondary_id

111982

Identifier Type: -

Identifier Source: org_study_id