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

September 22, 2020 updated by: Novartis

An Open Extension Study to Phase IIb 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Clozapine
Other Names:
  • Clozaril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events during the long term treatment (until NDA approval)
Time Frame: Baseline to 52 weeks
Baseline to 52 weeks
Vital signs at every 4 weeks
Time Frame: Baseline to 52 weeks
Baseline to 52 weeks
Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)
Time Frame: Baseline to 52 weeks
Baseline to 52 weeks
ECG at every 12 weeks
Time Frame: Baseline to 52 weeks
Baseline to 52 weeks
Echo cardiogram at every 24 weeks
Time Frame: Baseline to 52 weeks
Baseline to 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to 52 weeks
Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
Time Frame: Baseline to 52 weeks
Baseline to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEX123J1202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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