Depressive DisorderNCT01077596

Carcinogenicity Study of Bupropion

An observational study of Depressive Disorder and Cancer, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Depressive Disorder, Cancer
What is being tested?: Regular bupropion use, Regular SSRI (Selective serotonin reuptake inhibitors) use and Regular TCA (Tricyclic antidepressants) use
How many people: 50,430 participants
Where: No sites listed yet
Study dates: Jun 2008to Mar 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

Who cannot join

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

About this study

Official title: 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.

Read the 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
Being tested: Regular bupropion use, Regular SSRI (Selective serotonin reuptake inhibitors) use, Regular TCA (Tricyclic antidepressants) use, Regular use of any other antidepressant
Keywords: Carcinogenicity, Case control, Bupropion
Medical subject headings: Depressive Disorder, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Regular bupropion useDrug
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) useDrug
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) useDrug
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 antidepressantDrug
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.

Study groups in NCT01077596
Study group	Role	What they receive
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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant
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.
Measured: January 1, 1996 - December 31, 2006

Secondary outcomes (6)

Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant
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.
Measured: January 1, 1996 - December 31, 2006
Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant
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.
Measured: January 1, 1996 - December 31, 2006
Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant
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.
Measured: January 1, 1996 - December 31, 2006
Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant
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.
Measured: January 1, 1996 - December 31, 2006
Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant
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.
Measured: January 1, 1996 - December 31, 2006
Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant
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.
Measured: January 1, 1996 - December 31, 2006

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Mar 2010

First posted1 Mar 2010 (estimated)
Study startJun 2008
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 50,430 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01077596
Sponsor's protocol ID: 111982
Other IDs: EPI40463, WEUKSTV1113
Status last verified: May 2017
First submitted: 25 Feb 2010
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Recruiting
Impact of Psychomotor Therapy on the Quality of Life in Depression
Major Depressive Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Major Depressive Disorder (MDD), Depression in Adults
RecruitingPhase 1/2
Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder
Major Depression, Healthy Participants

All Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-marketing Carcinogenicity Study of Bupropion
ClinicalTrials.gov ID: NCT01077596
Acronym / sponsor ID: 111982
Conditions: Depressive Disorder, Cancer
Keywords: Carcinogenicity, Case control, Bupropion
Study type: Observational
Recruitment status: Completed
Enrolment: 50,430 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 1 Mar 2010 (estimated)
Results: Posted 10 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
New users of antidepressants Jan. 1, 1996 to Dec. 31, 2006	–	Drug: Regular bupropion use, Drug: Regular SSRI (Selective serotonin reuptake inhibitors) use, Drug: Regular TCA (Tricyclic antidepressants) use, Drug: Regular use of any other antidepressantAll 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (1 listed)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Regular bupropion useRegular 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	New users of antidepressants Jan. 1, 1996 to Dec. 31, 2006
Regular SSRI (Selective serotonin reuptake inhibitors) useRegular 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	New users of antidepressants Jan. 1, 1996 to Dec. 31, 2006
Regular TCA (Tricyclic antidepressants) useRegular 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	New users of antidepressants Jan. 1, 1996 to Dec. 31, 2006
Regular use of any other antidepressantRegular 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.	Drug	New users of antidepressants Jan. 1, 1996 to Dec. 31, 2006

Primary outcome

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
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.

6 secondary outcomes

Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Time frame: January 1, 1996 - December 31, 2006
Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Time frame: January 1, 1996 - December 31, 2006
Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Time frame: January 1, 1996 - December 31, 2006
Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Time frame: January 1, 1996 - December 31, 2006
Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Time frame: January 1, 1996 - December 31, 2006
Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant
Time frame: January 1, 1996 - December 31, 2006

Results and safety

Results posted to the registry on 10 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
New Antidepressant Exposure in Colorectal Cancer: Cases	350	350
New Antidepressant Exposure in Colorectal Cancer: Controls	1,050	1,050
New Antidepressant Exposure in Lung Cancer: Cases	457	457
New Antidepressant Exposure in Lung Cancer: Controls	1,370	1,370
New Antidepressant Exposure in Bladder Cancer: Cases	294	294
New Antidepressant Exposure in Bladder Cancer: Controls	882	882
Antidepressant Exposure in Uterine Cancer: Cases	308	308
New Antidepressant Exposure in Uterine Cancer: Controls	837	837
New Antidepressant Exposure in Breast Cancer: Cases	2,842	2,842
New Antidepressant Exposure in Breast Cancer: Controls	28,420	28,420
New Antidepressant Exposure in Prostate Cancer: Cases	2,215	2,215
New Antidepressant Exposure in Prostate Cancer: Controls	22,150	22,150

Primary outcome: 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. Number. Unit: participants

Measure	Bupropion, Regular Use n = 8038	All Non-bupropion Antidepressants, Regular Use n = 42392	Tricyclic Antidepressants (TCA), Regular Use n = 18537	Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use n = 23740	Other Antidepressants, Regular Use n = 10123
Cases	853	4561	1963	2570	1027
Controls	6332	37831	16574	21170	9096

Bupropion, Regular Use vs All Non-bupropion Antidepressants, Regular Use: Crude Odds Ratio: 1.2 (95% CI 1.1 to 1.3)
Bupropion, Regular Use vs All Non-bupropion Antidepressants, Regular Use: Adjusted Odds Ratio: 1.1 (95% CI 1.0 to 1.2)
Bupropion, Regular Use vs Tricyclic Antidepressants (TCA), Regular Use: Crude Odds Ratio: 1.2 (95% CI 1.1 to 1.3)

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

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
New Antidepressant Exposure in Colorectal Cancer: Cases	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Colorectal Cancer: Controls	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Lung Cancer: Cases	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Lung Cancer: Controls	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Bladder Cancer: Cases	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Bladder Cancer: Controls	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Uterine Cancer: Cases	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Uterine Cancer: Controls	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Breast Cancer: Cases	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Breast Cancer: Controls	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Prostate Cancer: Cases	0 of 0	0 of 0	Not reported
New Antidepressant Exposure in Prostate Cancer: Controls	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Depressive Disorder

RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Recruiting
Impact of Psychomotor Therapy on the Quality of Life in Depression
Major Depressive Disorder
RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
RecruitingPhase 3
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Major Depressive Disorder (MDD), Depression in Adults
RecruitingPhase 1/2
Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive Disorder
Major Depression, Healthy Participants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Depressive Disorder and Cancer, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01077596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017; AzTrials last refreshed its copy on 31 Oct 2026.