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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191555
First received: September 12, 2005
Last updated: June 8, 2012
Last verified: July 2006
  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

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191555

  Show 62 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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 April 23, 2014