NCT00250575

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_3 schizophrenia

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

4.1 years

First QC Date

November 7, 2005

Last Update Submit

April 20, 2016

Conditions

Schizophrenia

Keywords

Schizophrenia, treatment-resistant, clozapine

Outcome Measures

Primary Outcomes (3)

  • Values of hematological tests during the 24 week treatment

  • Incidence of hematological adverse events during the 24 week treatment

  • Compliance to Clozapine Patient Monitoring System during the 24 week treatment

Secondary Outcomes (3)

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

  • Global change in severity of psychosis at baseline and week 12

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

Study Arms (1)

1

EXPERIMENTAL
Drug: Clozapine

Interventions

ClozapineDRUG
Also known as: Clozaril
1

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed as schizophrenia
  • Not responded to at least two atypical antipshychotics launched in Japan
  • Inpatient

You may not qualify if:

  • Low white blood cell count
  • Significant heart diseases
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigational Site

Chiba, Japan

Location

Novartis Investigative Site

Fukuoka, Japan

Location

Novartis Investigative Site

Ishikawa, Japan

Location

Novartis Investigative Site

Osaka, Japan

Location

Novartis Investigative Site

Saga, Japan

Location

Novartis Investigative Site

Tokyo, Japan

Location

Novartis Investigative Site

Toyama, Japan

Location

Novartis Investigative Site

Yamanashi, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 8, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2009

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations

JP(8)