Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment
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|ClinicalTrials.gov Identifier: NCT00191555|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: olanzapine Drug: haloperidol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||August 2003|
|Study Completion Date :||May 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|