Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00154258
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Clozapine Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia
Study Start Date : April 2001
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1 Drug: Clozapine
Other Name: Clozaril


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154258


Sponsors and Collaborators
Novartis
Investigators
Layout table for investigator information
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00154258    
Other Study ID Numbers: CLEX123J1202
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: March 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis:
Schizophrenia, treatment-resistant, clozapine
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents