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

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 Overview

• Status: Completed
• Conditions: Depression; Suicide

• Study Type: Observational
• Enrollment (Actual): 254432

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
1; Duloxetine
2; Venlafaxine
3; SSRI
4; TCA
5; Multiple Antidepressants
6; Depressed (not antidepressant treated)
7; General population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of suicide attempt resulting in medical encounter or hospitalization.	Endpoint

Secondary Outcome Measures

Outcome Measure	Time Frame
Relative risk of suicide attempt resulting in medical encounters or hospitalization	Endpoint

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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 record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 30, 2008
• First Submitted That Met QC Criteria: September 30, 2008
• First Posted (Estimate): October 1, 2008

Study Record Updates

• Last Update Posted (Estimate): March 10, 2010
• Last Update Submitted That Met QC Criteria: March 9, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: 12016; F1J-MC-B027