Zyprexa® Relprevv™ Patient Care Program

• Conditions: Schizophrenia

• Registration Number: NCT01088386
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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).

Detailed Description

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:

1. 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;

2. 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

3. 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

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

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Exclusion Criteria

• Any patient not receiving Zyprexa Relprevv

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events	Baseline to end of study

Secondary Outcome Measures

Name	Time	Method
Type of post-injection delirium/sedation syndrome (PDSS) by clinical presentation and outcome	Baseline to end of study
Potential risk factors of post-injection delirium/sedation syndrome (PDSS).	Baseline to end of study

Trial Locations

Locations (1)

United BioSource Corporation; 🇺🇸 Blue Bell, Pennsylvania, United States