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A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250575
First Posted: November 8, 2005
Last Update Posted: April 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose

Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.

This study is not recruiting in the United States.


Condition Intervention Phase
Schizophrenia Drug: Clozapine Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 24-week, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Values of hematological tests during the 24 week treatment
  • Incidence of hematological adverse events during the 24 week treatment
  • Compliance to Clozapine Patient Monitoring System during the 24 week treatment

Secondary Outcome Measures:
  • Changes in the symptoms of psychosis every 4 weeks up to week 24
  • Global change in severity of psychosis at baseline and week 12
  • Global impression of change in the condition of patients at week 12 and 24

Enrollment: 43
Study Start Date: November 2005
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Clozapine
Other Name: Clozaril

Detailed Description:
Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed as schizophrenia
  • Not responded to at least two atypical antipshychotics launched in Japan
  • Inpatient

Exclusion Criteria:

  • Low white blood cell count
  • Significant heart diseases
  • Diabetes mellitus

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250575


Locations
Japan
Novartis Investigational Site
Chiba, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Ishikawa, Japan
Novartis Investigative Site
Osaka, Japan
Novartis Investigative Site
Saga, Japan
Novartis Investigative Site
Tokyo, Japan
Novartis Investigative Site
Toyama, Japan
Novartis Investigative Site
Yamanashi, Japan
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00250575     History of Changes
Other Study ID Numbers: CLEX123J1301
First Submitted: November 7, 2005
First Posted: November 8, 2005
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Novartis:
Schizophrenia, treatment-resistant, clozapine

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents