Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Double-Blind Long-term Study Comparing the Efficacy and Safety of Olanzapine Versus Haloperidol in Patients With Schizophrenia Previously Stabilized With Conventional Antipsychotic Treatment|
- 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).
- 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
- Intention Reading Task in a real-life situation
- Patient Outcome based on Preference Tool: POP
- Patient's quality of life: S-QOL
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||May 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191555
Show 62 Study Locations
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|