Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia (COES)

This study has been completed.
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Commonwealth Research Center, Massachusetts
Eli Lilly and Company
Information provided by (Responsible Party):
AlanGreen, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00169065
First received: September 10, 2005
Last updated: April 6, 2015
Last verified: April 2015

September 10, 2005
April 6, 2015
August 1998
June 2002   (final data collection date for primary outcome measure)
Changes in quality of life.
Same as current
Complete list of historical versions of study NCT00169065 on ClinicalTrials.gov Archive Site
Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.
Same as current
Not Provided
Not Provided
 
Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia
Clozapine vs. Olanzapine: An Effectiveness Study

This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Clozapine
  • Drug: Olanzapine
  • Active Comparator: Clozapine
    Clozapine or olanzapine in treatment resistant schizophrenia
    Intervention: Drug: Clozapine
  • Active Comparator: olanzapine
    clozapine or olanzapine in treatment resistant schizophrenia
    Intervention: Drug: Olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
June 2002
June 2002   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00169065
R01MH049891, R01MH049891
Yes
AlanGreen, National Institute of Mental Health (NIMH)
Harvard Medical School
  • National Institute of Mental Health (NIMH)
  • Dartmouth-Hitchcock Medical Center
  • Commonwealth Research Center, Massachusetts
  • Eli Lilly and Company
Principal Investigator: Alan I Green, MD Harvard Medical School
Harvard Medical School
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP