NCT00763724

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254,432

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Status
completed

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

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 10, 2010

Status Verified

March 1, 2010

Enrollment Period

1.4 years

First QC Date

September 30, 2008

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

DepressionSuicide

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-Injurious Behavior

Study Officials

  • 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 DIRECTOR

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