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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763724
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : March 10, 2010
Sponsor:
Information provided by:
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.

Condition or disease
Depression Suicide

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Study Type : Observational
Actual Enrollment : 254432 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : June 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Incidence of suicide attempt resulting in medical encounter or hospitalization. [ Time Frame: Endpoint ]

Secondary Outcome Measures :
  1. Relative risk of suicide attempt resulting in medical encounters or hospitalization [ Time Frame: Endpoint ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763724


Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00763724    
Other Study ID Numbers: 12016
F1J-MC-B027
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: March 10, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
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Suicide
Suicide, Attempted
Behavioral Symptoms
Self-Injurious Behavior