Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: olanzapine Drug: haloperidol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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
| Estimated Enrollment: | 360 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00191555 History of Changes |
| Other Study ID Numbers: | 6589, F1D-FP-S029 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 8, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Haloperidol Olanzapine Haloperidol decanoate Antipsychotic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Gastrointestinal Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 21, 2013