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Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: September 12, 2005
Last updated: June 8, 2012
Last verified: July 2006
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
Intervention Model: Parallel Assignment
Masking: Double
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

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00191555

  Show 62 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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 Identifier: NCT00191555     History of Changes
Other Study ID Numbers: 6589
Study First Received: September 12, 2005
Last Updated: June 8, 2012

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Haloperidol decanoate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Dopamine Antagonists
Dopamine Agents
Anti-Dyskinesia Agents processed this record on September 19, 2017