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Sponsors and Collaborators: |
Dartmouth-Hitchcock Medical Center Janssen, LP |
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Information provided by: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00130923 |
The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.
Condition | Intervention | Phase |
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Schizophrenia Psychotic Disorders Substance Abuse Alcohol Abuse |
Drug: risperidone long-acting Drug: oral risperidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Risperidone Long-Acting for Alcohol and Schizophrenia Treatment (R-LAST) |
Estimated Enrollment: | 100 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Risperidone Long Acting
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Drug: risperidone long-acting
Dose 25.00, 37.50 or 50.00 mg q two weeks
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2: Active Comparator
Oral Risperidone aka Risperdal
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Drug: oral risperidone
0.50-6.00 mg oral risperidone qd
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Comorbid alcohol/substance use disorder (SUD) in people with schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patients. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia, the typical antipsychotic agents are of limited value in controlling alcohol/substance use in these patients. Extrapyramidal, dysphoric side effects of conventional neuroleptics may actually promote the use of substances in an attempt to counteract these effects. In addition, medication non-compliance is common among patients with schizophrenia.
Novel antipsychotics have altered treatment expectations and outcomes for patients with severe forms of schizophrenia. A growing number of studies have assessed the effects of oral risperidone in persons with dual disorders. Potential mechanisms of action by which risperidone and other atypical antipsychotics could decrease substance use include being less likely to cause extrapyramidal side effects than typical agents, improving negative symptoms and ameliorating a dysfunction of the brain reward system. Risperidone long-acting injectable medication addresses issues of noncompliance, while avoiding peak blood levels of oral preparations, thereby minimizing EPS and improving negative symptoms of schizophrenia. Risperidone may also facilitate dopamine neurotransmission in the prefrontal cortex and correct a hypothesized dysfunction of the brain reward system.
This study is an open, randomized, controlled study to compare intramuscular long-acting risperidone to oral risperidone with blinded ratings to determine whether the long-acting form of risperidone has greater efficacy in reducing substance use. Patients with schizophrenia or schizoaffective disorder, age 18 to 65, who are taking any single oral antipsychotic medication except clozapine or risperidone long-acting may be enrolled.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
JMH Mental Health Center, University of Miami | |
Miami, Florida, United States, 33136 | |
United States, Missouri | |
School of Pharmacy, Univ. of Missouri Kansas City | |
Kansas City, Missouri, United States, 64108 | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
United States, New Hampshire | |
Mental Health Center of Greater Manchester | |
Manchester, New Hampshire, United States, 03101 | |
West Central Behavioral Health | |
Lebanon, New Hampshire, United States, 03766 | |
Center for Psychiatric Advancement | |
Nashua, New Hampshire, United States, 03060 | |
United States, South Carolina | |
University of South Carolina | |
Columbia, South Carolina, United States, 29203 | |
United States, Vermont | |
White River Junction Veterans Admininistration Medical Center | |
White River Junction, Vermont, United States, 05009 |
Principal Investigator: | Alan I. Green, MD | Dartmouth Medical School, Dartmouth College |
Responsible Party: | Dartmouth Medical School ( Alan I. Green, MD ) |
Study ID Numbers: | 17359, RIS-EMR-4032 |
Study First Received: | August 15, 2005 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00130923 History of Changes |
Health Authority: | United States: Institutional Review Board |
Risperidone Schizophrenia Substance Use Disorder |
Alcohol Use Disorder Treatment Schizoaffective Disorder |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Risperidone Central Nervous System Depressants Disorders of Environmental Origin Antipsychotic Agents Alcohol Drinking Serotonin Schizophrenia |
Dopamine Mental Disorders Alcoholism Substance-Related Disorders Dopamine Agents Psychotic Disorders Alcohol-Related Disorders Schizophrenia and Disorders with Psychotic Features Ethanol |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Schizophrenia Serotonin Antagonists Pathologic Processes Mental Disorders Therapeutic Uses Substance-Related Disorders Alcohol-Related Disorders Psychotic Disorders |
Schizophrenia and Disorders with Psychotic Features Disease Tranquilizing Agents Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Serotonin Agents Alcoholism Dopamine Agents Central Nervous System Agents |