NCT02334904|Unknown
Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
CARB
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CARB
Sponsor study identifier
observational
60
1 country
1
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Significant changes in brain morphology are observed in people with first-episode psychosis. Studies have shown that total brain volume and particular brain structures are decreased in people with psychosis disorders. Recent evidence suggests that some atypical antipsychotic drugs can maintain or increase brain volumes. Thus, we plan to use MRI scans to measure changes in brain morphology in subjects recently diagnosed with bipolar or psychosis disorders who are taking the atypical antipsychotic drugs aripiprazole or risperidone. Secondary objectives include taking blood samples for fasting metabolic indices and neuropsychiatric measures for comparisons between drug treatments.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 12, 2014
Actual (reported)January 8, 2015
Actual (reported)June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
MRI Brain Scans (Composite Measure)
Using structural MRI, we will measure total brain volume (TBV), grey matter volume (GMV), white matter volumes (WMV), and/or volumes of other brain structures.
Day 1 (Visit 1)
Metabolic Fasting Blood Work (Composite Measures)
Day 1 (Visit 1)
Genetic Measures (Composite Measure)
Day 1 (Visit 1)
Neuropsychological Assessments
At time of Day 1 (Only for those taking antipsychotic medications)
Psychiatric Assessment
At time of Day 1 (Only for those taking antipsychotic medications)
Participants receiving treatment of only aripiprazole, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.
Participants receiving treatment of only risperidone, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.
Healthy participants who are not taking any antipsychotic medications.
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study)
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
Patients admitted to Vancouver.Richmond EPI program who have been on at least 3 months of continuous antipsychotic drug treatment with either aripiprazole or risperidone for first-episode psychosis or bipolar disorder, and healthy controls.
BC Mental Health & Addictions Research Institute
Vancouver, British Columbia, V5Z 4H4, Canada
Participants will be offered the option of taking part in an optional biobanking component of the main study. Eight milliliters of whole blood samples will be collected and stored at -80 degrees Celsius for genotyping to determine if certain genetic polymorphisms predispose individuals to brain changes while taking antipsychotic medications.
Alasdair M Barr, Ph.D
University of British Columbia
Lili Kopala, M.D.
University of British Columbia
First Submitted
December 12, 2014
First Posted
January 8, 2015
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Estimated (date passed)A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 1, 2016
Record last verified: 2016-05
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Source: ClinicalTrials.gov.
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