Antidepressant Drug Exposure and Risk of Suicide Attempt Resulting in Medical Intervention in US Adults
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
2 other identifiers
observational
254,432
0 countries
N/A
Brief 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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedMarch 10, 2010
March 1, 2010
1.4 years
September 30, 2008
March 9, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of suicide attempt resulting in medical encounter or hospitalization.
Endpoint
Secondary Outcomes (1)
Relative risk of suicide attempt resulting in medical encounters or hospitalization
Endpoint
Study Arms (7)
1
Duloxetine
2
Venlafaxine
3
SSRI
4
TCA
5
Multiple Antidepressants
6
Depressed (not antidepressant treated)
7
General population
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2008
First Posted
October 1, 2008
Study Start
June 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
March 10, 2010
Record last verified: 2010-03