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OpenTrials
Completed

NCT Number: NCT00154258

A Long Term Study of Clozapine in Patients With Treatment-resistant Schizophrenia

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

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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 2

About this study

Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment 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

  • Attended the previous Phase IIb (core) study
  • Improved during the core study
  • No safety issues during the core study

Exclusion criteria

  • Discontinued the core study
  • Pregnant or nursing (lactating) women

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Clozapine

Drug

Other names: Clozaril

Primary outcomes

  1. Adverse events during the long term treatment (until NDA approval)

    Time frame: Baseline to 52 weeks

  2. Vital signs at every 4 weeks

    Time frame: Baseline to 52 weeks

  3. Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)

    Time frame: Baseline to 52 weeks

  4. ECG at every 12 weeks

    Time frame: Baseline to 52 weeks

  5. Echo cardiogram at every 24 weeks

    Time frame: Baseline to 52 weeks

Secondary outcomes

  1. Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks

    Time frame: Baseline to 52 weeks

  2. Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks

    Time frame: Baseline to 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Sep 12, 2005
Registry last updated
Sep 24, 2020

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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