CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50,430 enrolled
Drug / intervention
Regular bupropion use +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01077596
NCT01077596N/ACompleted

Post-marketing Carcinogenicity Study of Bupropion

GlaxoSmithKline·observational·Posted Mar 1, 2010·Updated May 30, 2017

In Brief

An observational study evaluating Regular bupropion use, Regular SSRI (Selective serotonin reuptake inhibitors) use, and 2 other interventions for Depressive Disorder and Cancer. Completed, enrolled 50,430 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2010
Enrollment StartJun 1, 2008
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.3 years ago

Interventions

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.