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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00191555
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment
• Scientific 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
• Date of first enrolment: August 2003
• Target sample size: 360
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00191555
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: olanzapine

Drug: haloperidol

Primary Outcome(s)

Psychiatric hospitalization.

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).

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).

The primary efficacy measure is defined as relapse. Relapse is defined by the presence of at least one of the following criteria:

Secondary Outcome(s)

The following secondary efficacy criteria will be measured at the times indicated in the Schedule of Events

Positive and negative symptom scale : PANSS

Patient Outcome based on Preference Tool: POP

Intention Reading Task in a real-life situation

Social Interactions measurement tools

Patient's quality of life: S-QOL

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

Secondary ID(s)

6589

F1D-FP-S029

Source(s) of Monetary Support

Please refer to primary and secondary sponsors