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Sponsored by: |
Centre for Addiction and Mental Health |
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Information provided by: | Centre for Addiction and Mental Health |
ClinicalTrials.gov Identifier: | NCT00716755 |
Since side effects of antipsychotics, dopamine D2 receptor blockers, frequently occur in older patients with schizophrenia and the risk is dose dependent, clinical guidelines universally advocate the use of lower doses.
However, there is no report to test this dosing guideline with measurements of D2 receptor blockade caused by antipsychotics. In this study, dopamine D2 receptor occupancy will be measured, using Positron Emission Tomography (PET), in 12 patients aged 50 and older with schizophrenia-spectrum disorders before and after a gradual 40 % dose reduction of antipsychotics that was safely achieved in the past study while setting a target dose still above the lower limit of the dose range recommended in clinical guidelines, i.e. 1.25 mg/day, for older patients. Our goal is to relate changes in clinical outcome, including subjective and objective clinical ratings, to dopamine D2 receptor occupancy, and compare these results with the data for younger patients in the literature.
Condition | Intervention |
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Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Delusional Disorder Psychotic Disorder |
Drug: Risperidone and PET scans |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Benefits of Optimizing Antipsychotic Doses and Their Relationship to Dopamine D2 Receptor Occupancy in Older Persons With Schizophrenia: a PET Study |
Estimated Enrollment: | 12 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Risperidone and PET scans
Current risperidone users who are 50 or older will be recruited. Dopamine D2 dopamine receptors using a selective D2 dopamine receptor ligand, [11C]-raclopride, and plasma levels of risperidone, 9-OH-risperidone, and prolactin will be measured on the 1st PET visit. Subsequently, the dose of risperidone will be gradually reduced by 0.5mg as long as the total reduction does not exceed 40%. At least 5 days after the termination of the dose taper, participants will have the second PET scan. Participants will be followed up for 12 weeks after the termination of the dose reduction.
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David C. Mamo, MD, MSc | 416-535-8501 ext 2876 | david_mamo@camh.net |
Canada, Ontario | |
Centre for Addiction and Mental Health | Recruiting |
Toronto, Ontario, Canada, M5T 1R8 | |
Principal Investigator: Hiroyuki Uchida, MD PhD | |
Sub-Investigator: David Mamo, MD | |
Sub-Investigator: Shitij Kapur, MD PhD | |
Sub-Investigator: Benoit Mulsant, MD | |
Sub-Investigator: Bruce Pollock, MD PhD |
Principal Investigator: | Hiroyuki Uchida, MD PhD | Centre for Addiction and Mental Health |
Responsible Party: | Centre for Addiction and Mental Health ( David Mamo MD; MSc ) |
Study ID Numbers: | 156/2007 |
Study First Received: | July 14, 2008 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00716755 History of Changes |
Health Authority: | Canada: Health Canada |
Positron emission tomography antipsychotics risperidone Dopamine D2 receptor occupancy elderly |
schizophrenia schizoaffective disorder schizophreniform disorder delusional disorder psychotic disorder NOS |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Risperidone Central Nervous System Depressants Cardiovascular Agents Antipsychotic Agents Serotonin Behavioral Symptoms Schizophrenia |
Schizophrenia, Paranoid Delusions Dopamine Mental Disorders Raclopride Psychotic Disorders Dopamine Agents Peripheral Nervous System Agents Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Psychotropic Drugs Schizophrenia Serotonin Antagonists Schizophrenia, Paranoid Dopamine Pathologic Processes Delusions Mental Disorders Therapeutic Uses Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Disease Tranquilizing Agents Sympathomimetics Risperidone Central Nervous System Depressants Dopamine Antagonists Cardiovascular Agents Antipsychotic Agents Protective Agents Pharmacologic Actions Behavioral Symptoms Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents |