Effectiveness of Clozapine Versus Olanzapine for Treatment-Resistant Schizophrenia
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Clozapine (Drug); Olanzapine (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Alan I Green, MD, Principal Investigator, Affiliation: Harvard University
Summary
This study will determine the effectiveness of clozapine versus olanzapine in treating people
with schizophrenia that has not improved with treatment.
Clinical Details
Official title: Clozapine Vs. Olanzapine: An Effectiveness Study
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Changes in quality of life.
Secondary outcome: Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.
Detailed description:
This is a two-year open-label, randomized trial of the comparative effectiveness of clozapine
versus olanzapine in patients with treatment refractory schizophrenia. The objective is to
determine whether in a naturalistic setting olanzapine is a logical treatment choice (before
using the more toxic clozapine) for some treatment refractory patients.
Eligibility
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 20-60 years;
- Diagnosis of treatment refractory schizophrenia or schizoaffective disorder;
- BPRS score > 21 (0-6) scale;
- Either two 6-8 week trials of typical neuroleptics given at a dosage of 600 mg/day of
CPZ or its equivalent or one 6-8 week trial of an atypical antipsychotic at a
reasonable dose (i. e. risperidone 4-6 mg/day);
- The patient (or the patient's authorized legal representative) must understand the
nature of the study and sign the informed consent;
- Clinically appropriate for clozapine or olanzapine
Exclusion Criteria:
- Current substance abuse;
- Suicide or homicide risk;
- Pregnancy or lactation;
- History of seizures or blood dyscrasias
Locations and Contacts
Commonwealth Research Center, Jamaica Plain, Massachusetts 02130, United States
Additional Information
Starting date: August 1998
Last updated: February 21, 2006
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