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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: olanzapine (Drug); haloperidol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Summary

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

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:

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

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Additional Information

Starting date: August 2003
Last updated: June 8, 2012

Page last updated: August 23, 2015

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