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

NCT ID: NCT00250575

Last Updated: 2016-04-21

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

PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy 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

* 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
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

Locations

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Novartis Investigational Site

Chiba, , Japan

Site Status

Novartis Investigative Site

Fukuoka, , Japan

Site Status

Novartis Investigative Site

Ishikawa, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Novartis Investigative Site

Saga, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Toyama, , Japan

Site Status

Novartis Investigative Site

Yamanashi, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CLEX123J1301

Identifier Type: -

Identifier Source: org_study_id

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