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Completed

NCT Number: NCT00250575

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigational Site, Chiba, Japan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clozapine

Drug

Other names: Clozaril

Primary outcomes

  1. Values of hematological tests during the 24 week treatment

  2. Incidence of hematological adverse events during the 24 week treatment

  3. Compliance to Clozapine Patient Monitoring System during the 24 week treatment

Secondary outcomes

  1. Changes in the symptoms of psychosis every 4 weeks up to week 24

  2. Global change in severity of psychosis at baseline and week 12

  3. Global impression of change in the condition of patients at week 12 and 24

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 24-week, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

Important dates

Study start
2005
Primary completion
2009
First posted
Nov 8, 2005
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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