Antidepressant Drug Exposure and Risk of Suicide Attempt... | NCT00763724

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

NCT00763724

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Mar 10, 2010Estimated

Enrollment

254,432Actual

Phase

Not provided

Conditions

Depression
Suicide

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
F1J-MC-B027

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Sep 30, 2008

First Submission Date that Met QC Criteria

Sep 30, 2008

First Posted Date

Oct 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2010

Last Update Posted Date

Mar 10, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

254,432Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Duloxetine
2		Venlafaxine
3		SSRI
4		TCA
5		Multiple Antidepressants
6		Depressed (not antidepressant treated)
7		General population

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D013405	Suicide

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D016728	Self-Injurious Behavior

Browse Leaves

Not provided

Browse Branches

Not provided