Effectiveness of Clozapine Versus Olanzapine for Treatment-Resistant Schizophrenia

This study has been terminated.

First Received: September 10, 2005 Last Updated: February 21, 2006 History of Changes

Sponsor:	National Institute of Mental Health (NIMH)
Collaborators:	Dartmouth-Hitchcock Medical Center Harvard University Commonwealth Research Center Eli Lilly and Company
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00169065

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Clozapine Vs. Olanzapine: An Effectiveness Study

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine Clozapine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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.

Estimated Enrollment:	35
Study Start Date:	August 1998

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

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

National Institute of Mental Health (NIMH)

Dartmouth-Hitchcock Medical Center

Harvard University

Commonwealth Research Center

Eli Lilly and Company

Investigators

Principal Investigator:

Alan I Green, MD

Harvard University

More Information

No publications provided

Study ID Numbers:	X061694-2
Study First Received:	September 10, 2005
Last Updated:	February 21, 2006
ClinicalTrials.gov Identifier:	NCT00169065 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Clozapine
olanzapine

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Schizophrenia
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents

Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
GABA Antagonists
Serotonin Agents
Autonomic Agents
Clozapine
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010