Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00056498

Purpose

This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.

Condition	Intervention	Phase
Schizophrenia	Drug: Placebo Drug: Risperdal	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clozapine Treatment of Schizophrenic Patients

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Clozapine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Measured at baseline and every 2 weeks for 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neuropsychological testing [ Time Frame: Measured at baseline and Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	December 2001
Estimated Study Completion Date:	December 2007
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Active Participants assigned to risperidone	Drug: Risperdal Risperdal 4 mg per day for 16 weeks Other Name: Risperidone
Placebo Comparator: Placebo Participants assigned to placebo	Drug: Placebo Placebo capsule daily for 16 weeks

Detailed Description:

Clozapine is the only antipsychotic drug that has been approved for treatment resistant patients with schizophrenia. However, up to 50% of patients treated with clozapine fail to respond and continue to exhibit clinically significant residual positive and negative symptoms and cognitive impairments. An emerging trend in treatment is the addition of a second antipsychotic drug. This study will determine if risperidone when given as adjunctive treatment is more effective than placebo in treating schizophrenic patients failing clozapine therapy.

Participants are randomly assigned to add either adjunctive risperidone or placebo to their current clozapine treatment in a single, daily dose for 16 weeks. Positive and negative symptoms, cognitive impairments, side effects of the treatment, anxiety, depression, hostility symptoms, and quality of life are assessed. Neurological tests, self administered questionnaires, and interviews are used to assess patients.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DSM-IV criteria for schizophrenia or schizoaffective disorder
Current clozapine treatment
Moderate illness severity and inadequate positive symptom response to clozapine treatment
6 month period of clozapine treatment with documented clozapine blood level greater than or equal to 350 ng/ml or clozapine and norclozapine blood level greater than or equal to 450 ng/ml

Exclusion Criteria:

Organic brain disorder
Mental retardation
Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
Pregnancy
DSM-IV criteria for current alcohol or substance dependence within the last 6 months or DSM-IV criteria for alcohol or substance abuse within the last month
Previously received adjunctive risperidone (at doses greater than or equal to 8 mg/day) with their clozapine treatment for greater than or equal to 6 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056498

Locations

United States, Maryland
Maryland Psychiatric Research Center	Recruiting
Baltimore, Maryland, United States, 21228
Contact: Melissa Bachmann 410-402-6042
Contact: Mary Ramsey 410-402-6060
Principal Investigator: Robert W. Buchanan, MD
Sub-Investigator: Robert C Conley, MD
Sub-Investigator: Elaine Weiner, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Robert W Buchanan, MD

University of Maryland

More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Weiner E, Conley RR, Ball MP, Feldman S, Gold JM, Kelly DL, Wonodi I, McMahon RP, Buchanan RW. Adjunctive risperidone for partially responsive people with schizophrenia treated with clozapine. Neuropsychopharmacology. 2010 Oct;35(11):2274-83. Epub 2010 Jul 21.

Responsible Party:	Robert W. Buchanan, MD, Maryland Psychiatric Research Center/University of Maryland Baltimore
ClinicalTrials.gov Identifier:	NCT00056498 History of Changes
Other Study ID Numbers:	R01 MH45074, DSIR 83-ATAP
Study First Received:	March 14, 2003
Last Updated:	March 4, 2008
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Risperidone
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
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on February 09, 2012