Zyprexa® Relprevv™ Patient Care Program

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01088386

Enrollment

4000

Registered

2010-03-17

Start date

2010-03-03

Completion date

2026-06-01

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Any patient not receiving Zyprexa Relprevv

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

STUDY_DIRECTORCall 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

Outcome results