Zyprexa® Relprevv™ Patient Care Program

Lilly

Status: Invitation-only

Conditions: Schizophrenia

Study type: Observational

Funder types: Industry

Identifiers

NCT01088386

F1D-MC-B041 (Other Identifier)

12991

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Any patient not receiving Zyprexa Relprevv

Trial design

4,000 participants in 1 patient group

Patients

Description:

All patients who will be receiving Zyprexa Relprevv must be enrolled into the Zyprexa Relprevv Patient Care Program