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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00056498 |
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 |
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Schizophrenia |
Drug: Placebo Drug: Risperdal |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clozapine Treatment of Schizophrenic Patients |
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: Active Comparator
Participants assigned to risperidone
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Drug: Risperdal
Risperdal 4 mg per day for 16 weeks
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Placebo: Placebo Comparator
Participants assigned to placebo
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Drug: Placebo
Placebo capsule daily for 16 weeks
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Robert W Buchanan, MD | Maryland Psychiatric Research Center |
Responsible Party: | Maryland Psychiatric Research Center/University of Maryland Baltimore ( Robert W. Buchanan, MD ) |
Study ID Numbers: | R01 MH45074, DSIR 83-ATAP |
Study First Received: | March 14, 2003 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00056498 |
Health Authority: | United States: Federal Government |
Schizophrenia Dopamine Mental Disorders Clozapine |
Risperidone Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |