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

April 6, 2015 updated by: AlanGreen, Harvard Medical School (HMS and HSDM)

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Jamaica Plain, Massachusetts, United States, 02130
        • Commonwealth Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Clozapine
Clozapine or olanzapine in treatment resistant schizophrenia
Drug: Clozapine
ACTIVE_COMPARATOR: olanzapine
clozapine or olanzapine in treatment resistant schizophrenia
Drug: Olanzapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Changes in quality of life.

Secondary Outcome Measures

Outcome Measure
Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Medical School (HMS and HSDM)

Collaborators

National Institute of Mental Health (NIMH)
Eli Lilly and Company
Dartmouth-Hitchcock Medical Center
Commonwealth Research Center, Massachusetts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Primary Completion (ACTUAL)

June 1, 2002

Study Completion (ACTUAL)

June 1, 2002

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH049891 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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