Behaviors and Mental Disorders

All Conditions

Depression

Depressive Disorder

Mood Disorders

Mental Disorders

Psychotic Disorders

Psychotropic Drugs

All Drugs and Chemicals

Cardiotonic Agents

Antidepressive Agents

Bupropion

Selective Serotonin Reuptake Inhibitors

Serotonin

Antidepressive Agents, Tricyclic

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Serotonin Receptor Agonists

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 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 bupropion 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.

Regular SSRI (Selective serotonin reuptake inhibitors) 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.

Regular TCA (Tricyclic antidepressants) use

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.

Regular use of any other antidepressant

GSK Clinical Trials

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.

Carcinogenicity Study of Bupropion

Post-marketing Carcinogenicity Study of Bupropion

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.

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.

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.

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.

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.

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.

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.

GlaxoSmithKline

This is a retrospective study of pre-existing data; thus, no assessments for Serious or Non-serious Adverse Events were performed.

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases

New Antidepressant Exposure in Colorectal Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls

New Antidepressant Exposure in Colorectal Cancer: Controls

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases

New Antidepressant Exposure in Lung Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls

New Antidepressant Exposure in Lung Cancer: Controls

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases

New Antidepressant Exposure in Bladder Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls

New Antidepressant Exposure in Bladder Cancer: Controls

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases

New Antidepressant Exposure in Uterine Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls

New Antidepressant Exposure in Uterine Cancer: Controls

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases

New Antidepressant Exposure in Breast Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls

New Antidepressant Exposure in Breast Cancer: Controls

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases

New Antidepressant Exposure in Prostate Cancer: Cases

New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls

New Antidepressant Exposure in Prostate Cancer: Controls

Total

45-54 years

55-64 years

65-74 years

>=75 years

Age, Customized

Sex: Female, Male

Exposed to multiple antidepressants

Ever smokers

Unknown smoking status

Ever diagnosed (dx) with depression

Ever dx with inflammatory bowel disease (IBD)

Users of oral contraceptives (OC)

Users of hormone replacement therapy (HRT)

Users of NSAIDs

A value of "0" indicates that no data are available for that particular treatment arm. Smoking status data were not collected for breast cancer and prostate cancer cases and controls, as it is not a necessary variable for analysis. NSAIDS, non-steroidal anti-inflammatory drugs.

Number of participants diagnosed with the indicated conditions and using the indicated therapies

GSK Response Center

Cases

Controls

Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date

Bupropion, Regular Use

Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date

All Non-bupropion Antidepressants, Regular Use

Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date

Tricyclic Antidepressants (TCA), Regular Use

Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date

Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use

Regular "other" antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date

Other Antidepressants, Regular Use

Participants diagnosed with colorectal, lung, bladder, uterus, breast, or prostate cancer who were new antidepressant users

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

Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date

Regular 'other' antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date

Participants diagnosed with colorectal cancer who were new antidepressant users.

Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Participants diagnosed with lung cancer who were new antidepressant users.

Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Participants diagnosed with bladder cancer who were new antidepressant users.

Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Participants diagnosed with uterine cancer who were new antidepressant users.

Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Participants diagnosed with breast cancer who were new antidepressant users.

Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant

Participants diagnosed with prostate cancer who were new antidepressant users.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Carcinogenicity Study of Bupropion	NCT01077596	Depressive Diso... Cancer	Regular bupropi... Regular SSRI (S... Regular TCA (Tr... Regular use of ...	18 Years -	GlaxoSmithKline
Carcinogenicity Study of Bupropion	NCT01077596	Depressive Diso... Cancer	Regular bupropi... Regular SSRI (S... Regular TCA (Tr... Regular use of ...	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for carcinogenicity