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

Completed

• Conditions: Suicide; Depression

• Registration Number: NCT00763724
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-09
• Last Update Posted: 2010-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254432

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).

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of suicide attempt resulting in medical encounter or hospitalization.	Endpoint

Secondary Outcome Measures

Name	Time	Method
Relative risk of suicide attempt resulting in medical encounters or hospitalization	Endpoint