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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00154258

Purpose

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	Intervention	Phase
Schizophrenia	Drug: Clozapine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Clozapine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks

Enrollment:	19
Study Start Date:	January 2002
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Clozapine Other Name: Clozaril

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154258

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00154258 History of Changes
Other Study ID Numbers:	CLEX123J1202
Study First Received:	September 8, 2005
Last Updated:	May 10, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Schizophrenia, treatment-resistant, clozapine

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on February 09, 2012