Double-Blind Long-term Study Comparing the Efficacy and Safety of Olanzapine Versus Haloperidol in Patients With Schizophrenia Previously Stabilized With Conventional Antipsychotic Treatment

Eli Lilly and Company1 site in 1 country360 target enrollmentAugust 2003

ConditionsSchizophrenia

Drugsolanzapine haloperidol

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Eli Lilly and Company
Enrollment: 360
Locations: 1
Primary Endpoint: The primary efficacy measure is defined as relapse. Relapse is defined by the presence of at least one of the following criteria:
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to demonstrate that there is a benefit in switching chronic schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy, neurological safety and patient's outcome.

Registry

clinicaltrials.gov

Start Date

August 2003

End Date

May 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Schizophrenic patient meeting the DSM-IV diagnostic criteria more than one year ago and treated with antipsychotic for at least 1 year.
•Outpatient (or patient admitted to hospital for social or logistic reasons).
•Patient receiving a stable dose of the same conventional antipsychotic for at least 8 weeks before visit
•Patient presenting a PANSS score equal or greater than 49 at Visit
•Patient considered by the investigator as possible candidates for a switch, owing to inadequate efficacy or poor safety of the current treatment.

Exclusion Criteria

•Patient presenting a schizophreniform or a schizo-affective disorder according to the DSM-IV diagnostic criteria, or any other disorder from Axis I of the DSM-IV, or a disorder from Axis II (limit personality), substance dependence or substance abuse.
•Administration of an atypical antipsychotic drug during the 8 weeks preceding V
•History of resistance to antipsychotic drugs
•Hospitalization in a psychiatric unit or in a psychiatric emergency department within the 8 weeks preceding the beginning of the study.
•Presence of serious unstable disease, such as a fatal outcome or hospitalization in an intensive care unit, is foreseeable within a period of 6 months.

Outcomes

Primary Outcomes

The primary efficacy measure is defined as relapse. Relapse is defined by the presence of at least one of the following criteria:

Psychiatric hospitalization.

A 25% increase in the total score on the PANSS scale (Kay SR et al. 1987) in relation to the score obtained at the baseline visit (Visit 2).

A major deterioration in clinical condition, defined by a score of 6 ("much worse") or 7 ("very much worse") on the CGI-I scale (Clinical Global Impression-Improvement)

Suicide attempt requiring medical treatment and/or jeopardizing vital prognosis (self-mutilation, ingestion of a toxic substance, defenestration, self-mutilation with suicidal intent).

Secondary Outcomes

Intention Reading Task in a real-life situation
The following secondary efficacy criteria will be measured at the times indicated in the Schedule of Events
Positive and negative symptom scale : PANSS
Clinical global impression scale: CGI [Clinical global impression-severity of illness (CGI-S); Clinical global impression-improvement of illness (CGI-I); Clinical Global Impression scale - Psychic distress]
Schizophrenic Communication Disorder Rating Scale: SCD
Social Interactions measurement tools
Patient Outcome based on Preference Tool: POP
Patient's quality of life: S-QOL