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

NCT ID: NCT00763724

Last Updated: 2010-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

254432 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-11-30

Brief Summary

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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

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Conditions

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Depression Suicide

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Duloxetine

No interventions assigned to this group

2

Venlafaxine

No interventions assigned to this group

3

SSRI

No interventions assigned to this group

4

TCA

No interventions assigned to this group

5

Multiple Antidepressants

No interventions assigned to this group

6

Depressed (not antidepressant treated)

No interventions assigned to this group

7

General population

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Other Identifiers

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F1J-MC-B027

Identifier Type: -

Identifier Source: secondary_id

12016

Identifier Type: -

Identifier Source: org_study_id

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