DepressionNCT00763724
Antidepressant Drug Exposure and Risk of Suicide Attempt Resulting in Medical Intervention in US Adults
An observational study of Depression and Suicide, run by Eli Lilly and Company.
Trial summary
The primary objective of the study is to estimate the incidence of suicide attempts resulting in a medical encounter or hospitalization in seven propensity matched cohorts of subjects: patients treated with duloxetine for depression, patients treated with one of three other antidepressants or antidepressant classes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Suicide
- How many people
- 254,432 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Nov 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be based on data from the PharMetrics Patient-Centric Database, a commercially available claims database provided by PharMetrics, Inc., a Unit of IMS.
Who may be able to join
- Age 18 years or older at index date
- Have at least 6 months of continuous enrollment data prior to index date.
- Have complete medical, facility, and pharmacy records (the latter of which will include complete quantity and days supplied information).
Who cannot join
- None
About this study
Official title: A Propensity-Matched Retrospective Cohort Study of Antidepressant Drug Exposure and Risk of Suicide Attempt in Adults From a Large U.S. Managed Care Population
The primary objective of the study is to estimate the incidence of suicide attempts resulting in a medical encounter or hospitalization in seven propensity matched cohorts of subjects: patients treated with duloxetine for depression, patients treated with one of three other antidepressants or antidepressant classes (venlafaxine, SSRIs, or TCAs) for depression, patients treated with multiple antidepressants for depression (either concurrently or consecutively), depressed patients with no pharmacologic treatment, and a non-depressed general population sample.
- Conditions
- Depression, Suicide
- Medical subject headings
- Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Duloxetine | |
| 2 | Venlafaxine | |
| 3 | SSRI | |
| 4 | TCA | |
| 5 | Multiple Antidepressants | |
| 6 | Depressed (not antidepressant treated) | |
| 7 | General population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of suicide attempt resulting in medical encounter or hospitalization.
Measured: Endpoint
Secondary outcomes (1)
Relative risk of suicide attempt resulting in medical encounters or hospitalization
Measured: Endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 254,432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763724
- Sponsor's protocol ID
- 12016
- Other IDs
- F1J-MC-B027
- Status last verified
- Mar 2010
- First submitted
- 30 Sep 2008
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Propensity-Matched Retrospective Cohort Study of Antidepressant Drug Exposure and Risk of Suicide Attempt in Adults From a Large U.S. Managed Care Population
- ClinicalTrials.gov ID
- NCT00763724
- Acronym / sponsor ID
- 12016
- Conditions
- Depression, Suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254,432 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 1 Oct 2008 (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.
The primary objective of the study is to estimate the incidence of suicide attempts resulting in a medical encounter or hospitalization in seven propensity matched cohorts of subjects: patients treated with duloxetine for depression, patients treated with one of three other antidepressants or antidepressant classes (venlafaxine, SSRIs, or TCAs) for depression, patients treated with multiple antidepressants for depression (either concurrently or consecutively), depressed patients with no pharmacologic treatment, and a non-depressed general population sample.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Duloxetine |
| 2 | – | –Venlafaxine |
| 3 | – | –SSRI |
| 4 | – | –TCA |
| 5 | – | –Multiple Antidepressants |
| 6 | – | –Depressed (not antidepressant treated) |
| 7 | – | –General population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be based on data from the PharMetrics Patient-Centric Database, a commercially available claims database provided by PharMetrics, Inc., a Unit of IMS.
Key inclusion criteria (3 listed)
- Age 18 years or older at index date
- Have at least 6 months of continuous enrollment data prior to index date.
- Have complete medical, facility, and pharmacy records (the latter of which will include complete quantity and days supplied information).
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.
Primary outcome
Incidence of suicide attempt resulting in medical encounter or hospitalization.
Time frame: Endpoint
1 secondary outcome
Relative risk of suicide attempt resulting in medical encounters or hospitalization
Time frame: Endpoint
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 10 Mar 2010.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Suicide, run by Eli Lilly and Company.
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 3 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 10 Mar 2010. 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?
Incidence of suicide attempt resulting in medical encounter or hospitalization. (time frame: Endpoint). 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 10 Mar 2010.