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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Schizophrenia

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 Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Blue Bell, Pennsylvania, United States, 19422
      • United BioSource Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Clinical practices in the United States

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any patient not receiving Zyprexa Relprevv

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients; All patients who will be receiving Zyprexa Relprevv must be enrolled into the Zyprexa Relprevv Patient Care Program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 15, 2010
• First Submitted That Met QC Criteria: March 16, 2010
• First Posted (Estimated): March 17, 2010

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 12991; F1D-MC-B041 (Other Identifier: Eli Lilly and Company)