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OpenTrials
Completed

NCT Number: NCT00763724

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of suicide attempt resulting in medical encounter or hospitalization.

    Time frame: Endpoint

Secondary outcomes

  1. Relative risk of suicide attempt resulting in medical encounters or hospitalization

    Time frame: Endpoint

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 1, 2008
Registry last updated
Mar 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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