Depressive Disorder, MajorNCT02039960
PRJ2215: Assessment of Buproprion Misuse/Abuse 2004-2011
An observational study of Depressive Disorder, Major, run by GlaxoSmithKline.
Trial summary
Bupropion hydrochloride was first approved on 30 December 1985 in United States for depression and is currently approved in 80 countries. Bupropion has also subsequently been approved for smoking cessation and for seasonal affective disorder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Bupropion
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A DAWN case is any ED visit involving recent drug use. DAWN cases are identified through the review of ED medical records in participating hospitals. DAWN captures both ED visits that are directly caused by drugs and those in which drugs are a contributing factor but not the direct cause of the ED visit. These criteria encompass all types of drug-related events, including accidental ingestion and adverse reaction, as well as drug misuse or abuse. DAWN collects data on all types of drugs-illegal drugs, prescription and over-the-counter medications, dietary supplements, and both pharmaceutical and nonpharmaceutical inhalants. DAWN notes whether alcohol is involved in addition to drug(s) for patients of all ages. Because alcohol is considered an illicit drug for minors, alcohol abuse without the involvement of other drugs is considered a drug-related ED visit for patients under the age of 21. DAWN does not report current medications that are deemed to be unrelated to the ED visit.
Who may be able to join
- All DAWN case reports mentioning use of bupropion will be included in this analysis.
Who cannot join
- None
About this study
Bupropion hydrochloride was first approved on 30 December 1985 in United States for depression and is currently approved in 80 countries. Bupropion has also subsequently been approved for smoking cessation and for seasonal affective disorder.
Cumulative exposure to bupropion is estimated at approximately 97.3 million patient exposures up to 31 December 2012.
Read more
Bupropion hydrochloride is a weak catecholamine reuptake inhibitor predominantly affecting serotonin, norepinephrine and dopamine. Its mechanism of action and its structural similarities to diethylpropion, amphetamines, and cocaine, bupropion resembles stimulants in many respects, leading to concerns about potential abuse of the product.
Abuse potential had been part of the Benefit Risk Management Plan for bupropion up until 2003 and at that point, had no longer been regarded as a potential risk that required additional/further evaluation outside standard pharmacovigilance monitoring. The current European Risk Management Plan also states that standard pharmacovigilance monitoring applies to abuse potential. Monitoring has shown a recent increase in the number of spontaneous reports from the Adverse Event reporting System (AERS) of drug abuse.
The bupropion team agreed that although the numbers of abuse reports was small relative to the total number of reports for bupropion in OCEANS, there was sufficient information in AERS to warrant investigation of the potential effect on public health.
To investigate the degree of misuse and abuse of bupropion (including non-oral routes of administration) in the United States, the Drug Abuse Warning Network will be used to examine the study period 2004-2011.
Read the detailed description
There are two primary objectives to the study, which are as follows: 1) to examine the number of bupropion reports over time within the DAWN database and to describe the number of all DAWN reports for prescription drugs and 2) to examine the number of reports for bupropion, stratified by demographics, route of administration, and disposition of the patient.
If sample size permits, an evaluation of the disposition of the patients exposed to only bupropion at the time of Emergency Department (ED) visit will be conducted.
DAWN is a public health surveillance system that reports on drug-related visits to hospital Emergency Departments (ED). DAWN is used to monitor trends in drug misuse and abuse, identify the emergence of new substances and drug combinations, assess health hazards associated with drug use and abuse, and estimate the impact of drug use, misuse, and abuse on the United States' health care system.
DAWN's target sample frame consists of all non-Federal, short-stay, general medical and surgical hospitals in the United States that have one or more EDs open 24 hours a day. DAWN employs a multistage sampling design for the selection of EDs for analysis. Stratified simple random sampling with oversampling in selected metropolitan areas is used to select the hospitals.
A DAWN case is any ED visit involving recent drug use. DAWN cases are identified through the review of ED medical records in participating hospitals. DAWN captures both ED visits that are directly caused by drugs and those in which drugs are a contributing factor but not the direct cause of the ED visit. These criteria encompass all types of drug-related events, including accidental ingestion and adverse reaction, as well as drug misuse or abuse.
DAWN collects data on all types of drugs-illegal drugs, prescription and over-the-counter medications, dietary supplements, and both pharmaceutical and nonpharmaceutical inhalants. DAWN notes whether alcohol is involved in addition to drug(s) for patients of all ages. Because alcohol is considered an illicit drug for minors, alcohol abuse without the involvement of other drugs is considered a drug-related ED visit for patients under the age of 21. DAWN does not report current medications (i.e., medications and pharmaceuticals taken regularly by the patient as prescribed or indicated) that are deemed by the ED medical staff to be unrelated to the ED visit.
The study population includes patients of all ages presenting to emergency departments for drug-related causes. The DAWN visit eligibility criteria are intended to be broad and inclusive and to have few exceptions. They take into account the fact that documentation in medical records varies in clarity and completeness across hospitals and among clinicians within hospitals. The criteria are designed to minimize the potential for DAWN Reporter judgments that could cause data to vary systematically and unexpectedly across different data collectors and hospitals. In addition, the criteria allow for the capture of a diverse set of drug-related visits that can be aggregated or disaggregated to serve a variety of analytical purposes and the interests of multiple audiences.
There are few variables within the DAWN dataset. For this analysis, variables of interest can be grouped into the following categories: year of visit, age, sex, race, reason for presentation to the emergency department, case type, drug, route of administration, toxicology confirmed, and result of treatment in ED.
The Drug Abuse Warning Network datasets from 2004-2011 will be used for the proposed analyses.
All eligible DAWN cases will be included in this analysis.
- Conditions
- Depressive Disorder, Major
- Being tested
- Bupropion
- Keywords
- Epidemiology, Drug Abuse Warning Network (DAWN), bupropion, abuse
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Bupropion is a weak catecholamine reuptake inhibitor predominantly affecting serotonin, norepinephrine and dopamine and is approved for depression, smoking cessation and seasonal affective disorder.
| Study group | Role | What they receive |
|---|---|---|
| DAWN cases including all prescription drugs | This group will consist of all DAWN cases where prescription drugs are mentioned. Receives: Drug: Bupropion | |
| All bupropion cases (including use of other drugs) | This group will consist of all DAWN cases where bupropion is mentioned and is a subset of Group 1. Receives: Drug: Bupropion | |
| Burpropion Only Cases | This group will consist of all DAWN cases where burpropion is specifically the only drug mentioned within the case report, and is a subset of Group 2. Receives: Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of bupropion abuse case reports from the DAWN data.
Abuse case reports of interest include unlicensed route of administration, specifically, inhalation of bupropion.
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039960
- Sponsor's protocol ID
- 201235
- Other IDs
- PRJ2215
- Status last verified
- Aug 2016
- First submitted
- 9 Jan 2014
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRJ2215: Assessment of Buproprion Misuse/Abuse 2004-2011
- ClinicalTrials.gov ID
- NCT02039960
- Acronym / sponsor ID
- 201235
- Conditions
- Depressive Disorder, Major
- Keywords
- Epidemiology, Drug Abuse Warning Network (DAWN), bupropion, abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bupropion hydrochloride was first approved on 30 December 1985 in United States for depression and is currently approved in 80 countries. Bupropion has also subsequently been approved for smoking cessation and for seasonal affective disorder.
Cumulative exposure to bupropion is estimated at approximately 97.3 million patient exposures up to 31 December 2012.
Bupropion hydrochloride is a weak catecholamine reuptake inhibitor predominantly affecting serotonin, norepinephrine and dopamine. Its mechanism of action and its structural similarities to diethylpropion, amphetamines, and cocaine, bupropion resembles stimulants in many respects, leading to concerns about potential abuse of the product.
Abuse potential had been part of the Benefit Risk Management Plan for bupropion up until 2003 and at that point, had no longer been regarded as a potential risk that required additional/further evaluation outside standard pharmacovigilance monitoring. The current European Risk Management Plan also states that standard pharmacovigilance monitoring applies to abuse potential. Monitoring has shown a recent increase in the number of spontaneous reports from the Adverse Event reporting System (AERS) of drug abuse.
The bupropion team agreed that although the numbers of abuse reports was small relative to the total number of reports for bupropion in OCEANS, there was sufficient information in AERS to warrant investigation of the potential effect on public health.
To investigate the degree of misuse and abuse of bupropion (including non-oral routes of administration) in the United States, the Drug Abuse Warning Network will be used to examine the study period 2004-2011.
Detailed description
There are two primary objectives to the study, which are as follows: 1) to examine the number of bupropion reports over time within the DAWN database and to describe the number of all DAWN reports for prescription drugs and 2) to examine the number of reports for bupropion, stratified by demographics, route of administration, and disposition of the patient.
If sample size permits, an evaluation of the disposition of the patients exposed to only bupropion at the time of Emergency Department (ED) visit will be conducted.
DAWN is a public health surveillance system that reports on drug-related visits to hospital Emergency Departments (ED). DAWN is used to monitor trends in drug misuse and abuse, identify the emergence of new substances and drug combinations, assess health hazards associated with drug use and abuse, and estimate the impact of drug use, misuse, and abuse on the United States' health care system.
DAWN's target sample frame consists of all non-Federal, short-stay, general medical and surgical hospitals in the United States that have one or more EDs open 24 hours a day. DAWN employs a multistage sampling design for the selection of EDs for analysis. Stratified simple random sampling with oversampling in selected metropolitan areas is used to select the hospitals.
A DAWN case is any ED visit involving recent drug use. DAWN cases are identified through the review of ED medical records in participating hospitals. DAWN captures both ED visits that are directly caused by drugs and those in which drugs are a contributing factor but not the direct cause of the ED visit. These criteria encompass all types of drug-related events, including accidental ingestion and adverse reaction, as well as drug misuse or abuse.
DAWN collects data on all types of drugs-illegal drugs, prescription and over-the-counter medications, dietary supplements, and both pharmaceutical and nonpharmaceutical inhalants. DAWN notes whether alcohol is involved in addition to drug(s) for patients of all ages. Because alcohol is considered an illicit drug for minors, alcohol abuse without the involvement of other drugs is considered a drug-related ED visit for patients under the age of 21. DAWN does not report current medications (i.e., medications and pharmaceuticals taken regularly by the patient as prescribed or indicated) that are deemed by the ED medical staff to be unrelated to the ED visit.
The study population includes patients of all ages presenting to emergency departments for drug-related causes. The DAWN visit eligibility criteria are intended to be broad and inclusive and to have few exceptions. They take into account the fact that documentation in medical records varies in clarity and completeness across hospitals and among clinicians within hospitals. The criteria are designed to minimize the potential for DAWN Reporter judgments that could cause data to vary systematically and unexpectedly across different data collectors and hospitals. In addition, the criteria allow for the capture of a diverse set of drug-related visits that can be aggregated or disaggregated to serve a variety of analytical purposes and the interests of multiple audiences.
There are few variables within the DAWN dataset. For this analysis, variables of interest can be grouped into the following categories: year of visit, age, sex, race, reason for presentation to the emergency department, case type, drug, route of administration, toxicology confirmed, and result of treatment in ED.
The Drug Abuse Warning Network datasets from 2004-2011 will be used for the proposed analyses.
All eligible DAWN cases will be included in this analysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DAWN cases including all prescription drugs | – | Drug: BupropionThis group will consist of all DAWN cases where prescription drugs are mentioned. |
| All bupropion cases (including use of other drugs) | – | Drug: BupropionThis group will consist of all DAWN cases where bupropion is mentioned and is a subset of Group 1. |
| Burpropion Only Cases | – | Drug: BupropionThis group will consist of all DAWN cases where burpropion is specifically the only drug mentioned within the case report, and is a subset of Group 2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A DAWN case is any ED visit involving recent drug use. DAWN cases are identified through the review of ED medical records in participating hospitals. DAWN captures both ED visits that are directly caused by drugs and those in which drugs are a contributing factor but not the direct cause of the ED visit. These criteria encompass all types of drug-related events, including accidental ingestion and adverse reaction, as well as drug misuse or abuse. DAWN collects data on all types of drugs-illegal drugs, prescription and over-the-counter medications, dietary supplements, and both pharmaceutical and nonpharmaceutical inhalants. DAWN notes whether alcohol is involved in addition to drug(s) for patients of all ages. Because alcohol is considered an illicit drug for minors, alcohol abuse without the involvement of other drugs is considered a drug-related ED visit for patients under the age of 21. DAWN does not report current medications that are deemed to be unrelated to the ED visit.
Key inclusion criteria (1 listed)
- All DAWN case reports mentioning use of bupropion will be included in this analysis.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| BupropionBupropion is a weak catecholamine reuptake inhibitor predominantly affecting serotonin, norepinephrine and dopamine and is approved for depression, smoking cessation and seasonal affective disorder. | Drug | All bupropion cases (including use of other drugs), Burpropion Only Cases, DAWN cases including all prescription drugs |
Primary outcome
The number of bupropion abuse case reports from the DAWN data.
Time frame: Up to 8 years
Abuse case reports of interest include unlicensed route of administration, specifically, inhalation of bupropion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
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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, Major, 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 1 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 5 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of bupropion abuse case reports from the DAWN data. (time frame: Up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2016.