Antidepressant Drug Exposure and Risk of Suicide Attempt Resulting in Medical Intervention in US Adults

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763724
• Other study ID #: 12016
• Secondary ID: F1J-MC-B027
• Status: Completed
• Phase: N/A
• First received: September 30, 2008
• Last updated: March 9, 2010
• Start date: June 2008
• Est. completion date: November 2009

Study information

• Verified date: March 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254432
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Depression
• Suicide
• Suicide, Attempted

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of suicide attempt resulting in medical encounter or hospitalization.		Endpoint	Yes
Secondary	Relative risk of suicide attempt resulting in medical encounters or hospitalization		Endpoint	Yes