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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clozapine
Olanzapine
Sponsored by
Harvard Medical School (HMS and HSDM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Clozapine, olanzapine

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Commonwealth Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Clozapine

olanzapine

Arm Description

Clozapine or olanzapine in treatment resistant schizophrenia

clozapine or olanzapine in treatment resistant schizophrenia

Outcomes

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.

Full Information

First Posted
September 10, 2005
Last Updated
April 6, 2015
Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Institute of Mental Health (NIMH), Dartmouth-Hitchcock Medical Center, Commonwealth Research Center, Massachusetts, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00169065
Brief Title
Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia
Acronym
COES
Official Title
Clozapine vs. Olanzapine: An Effectiveness Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Institute of Mental Health (NIMH), Dartmouth-Hitchcock Medical Center, Commonwealth Research Center, Massachusetts, Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Clozapine, olanzapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clozapine
Arm Type
Active Comparator
Arm Description
Clozapine or olanzapine in treatment resistant schizophrenia
Arm Title
olanzapine
Arm Type
Active Comparator
Arm Description
clozapine or olanzapine in treatment resistant schizophrenia
Intervention Type
Drug
Intervention Name(s)
Clozapine
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Primary Outcome Measure Information:
Title
Changes in quality of life.
Secondary Outcome Measure Information:
Title
Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan I Green, MD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Commonwealth Research Center
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia

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