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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:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00250575
First received: November 7, 2005
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Clozapine
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00250575     History of Changes
Other Study ID Numbers: CLEX123J1301
Study First Received: November 7, 2005
Last Updated: May 3, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on June 17, 2013