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

NCT ID: NCT00154258

Last Updated: 2020-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Clozapine

Intervention Type DRUG

Interventions

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Clozapine

Intervention Type DRUG

Other Intervention Names

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Clozaril

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Other Identifiers

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CLEX123J1202

Identifier Type: -

Identifier Source: org_study_id

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