Schizophrenia
Conditions
Keywords
Clozapine, olanzapine
Brief summary
This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment.
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.
Interventions
DRUGClozapine
DRUGOlanzapine
Sponsors
National Institute of Mental Health (NIMH)
Dartmouth-Hitchcock Medical Center
Commonwealth Research Center, Massachusetts
Eli Lilly and Company
Harvard Medical School (HMS and HSDM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family. | — |
Countries
United States
Outcome results
None listed