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
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Clozapine
Drug: Olanzapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clozapine vs. Olanzapine: An Effectiveness Study

Resource links provided by NLM:


Further study details as provided by Harvard Medical School:

Primary Outcome Measures:
  • Changes in quality of life.

Secondary Outcome Measures:
  • Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.

Enrollment: 38
Study Start Date: August 1998
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clozapine
Clozapine or olanzapine in treatment resistant schizophrenia
Drug: Clozapine
Active Comparator: olanzapine
clozapine or olanzapine in treatment resistant schizophrenia
Drug: Olanzapine

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169065

Locations
United States, Massachusetts
Commonwealth Research Center
Jamaica Plain, Massachusetts, United States, 02130
Sponsors and Collaborators
Harvard Medical School
Dartmouth-Hitchcock Medical Center
Commonwealth Research Center, Massachusetts
Eli Lilly and Company
Investigators
Principal Investigator: Alan I Green, MD Harvard Medical School
  More Information

No publications provided

Responsible Party: AlanGreen, Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00169065     History of Changes
Other Study ID Numbers: R01MH049891, R01MH049891
Study First Received: September 10, 2005
Last Updated: April 6, 2015
Health Authority: United States: Federal Government

Keywords provided by Harvard Medical School:
Clozapine
olanzapine

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Clozapine
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 27, 2015