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OpenTrials
Enrolling by Invitation

NCT Number: NCT01088386

Zyprexa® Relprevv™ Patient Care Program

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS).

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

United BioSource Corporation

Blue Bell, Pennsylvania, 19422, United States

About this study

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:

  • Ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
  • Informing health care providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified healthcare facilities; and
  • Establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program registry.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patients receiving Zyprexa Relprevv enrolled in Zyprexa Relprevv Patient Care Program

Exclusion criteria

  • Any patient not receiving Zyprexa Relprevv

Treatment and study plan

Primary outcomes

  1. Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events

    Time frame: Baseline to end of study

Secondary outcomes

  1. Type of post-injection delirium/sedation syndrome (PDSS) by clinical presentation and outcome

    Time frame: Baseline to end of study

  2. Potential risk factors of post-injection delirium/sedation syndrome (PDSS).

    Time frame: Baseline to end of study

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2010
Registry last updated
Jan 28, 2026

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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