NCT Number: NCT00191555
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.
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Notify MeKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
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) , or speak with your personal physician, Aix-en-Provence, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 1.
Patient presenting a PANSS score equal or greater than 49 at Visit 2.
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 V1.
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.
Treatment and study plan
Haloperidol
DrugPrimary outcomes
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The primary efficacy measure is defined as relapse. Relapse is defined by the presence of at least one of the following criteria:
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Psychiatric hospitalization.
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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).
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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)
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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
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The following secondary efficacy criteria will be measured at the times indicated in the Schedule of Events
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Positive and negative symptom scale : PANSS
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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]
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Schizophrenic Communication Disorder Rating Scale: SCD
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Social Interactions measurement tools
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Intention Reading Task in a real-life situation
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Patient Outcome based on Preference Tool: POP
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Patient's quality of life: S-QOL
Sponsors and collaborators
Lead sponsor
Eli Lilly and Company
Industry
Registry information
Official study 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
Important dates
- Study start
- 2003
- Study completion
- 2006
- First posted
- Sep 19, 2005
- Registry last updated
- Jun 12, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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