Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI (CARB)
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|ClinicalTrials.gov Identifier: NCT02334904|
Recruitment Status : Unknown
Verified May 2016 by University of British Columbia.
Recruitment status was: Recruiting
First Posted : January 8, 2015
Last Update Posted : June 1, 2016
|Condition or disease||Intervention/treatment|
|First-Episode Psychosis Bipolar Disorder||Drug: Aripiprazole Drug: Risperidone|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Participants receiving treatment of only aripiprazole, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study)
Other Name: Abilify
Participants receiving treatment of only risperidone, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
Healthy participants who are not taking any antipsychotic medications.
- MRI Brain Scans (Composite Measure) [ Time Frame: Day 1 (Visit 1) ]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.
- Metabolic Fasting Blood Work (Composite Measures) [ Time Frame: Day 1 (Visit 1) ]By obtaining two tubes of fasting blood, we will determine fasting metabolic parameters of common blood components (lipids, cholesterol, leptin, adiponectin, glucose, and insulin).
- Genetic Measures (Composite Measure) [ Time Frame: Day 1 (Visit 1) ]An optional component, as obtained from blood work, will be to determine potential genetic variants in several candidate genes (such as BDNF) that predispose some subjects to changes in brain morphology.
- Neuropsychological Assessments [ Time Frame: At time of Day 1 (Only for those taking antipsychotic medications) ]To assess cognitive functioning for those subject's taking risperidone or aripiprazole, we will administer a set of standard scales and surveys to measure executive and cognitive functioning.
- Psychiatric Assessment [ Time Frame: At time of Day 1 (Only for those taking antipsychotic medications) ]To assess mental health symptoms for those subject's taking risperidone or aripiprazole, we will administer a set of interviews (PANSS and MINI) to assess mental health symptoms.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334904
|Contact: Heidi Boyda, Ph.Dfirstname.lastname@example.org|
|Contact: Delrae Fawcett, MSc||604-875-2000 ext email@example.com|
|Canada, British Columbia|
|BC Mental Health & Addictions Research Institute||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4H4|
|Contact: Delrae Fawcett, MSc 604-875-2000 ext 6115 firstname.lastname@example.org|
|Principal Investigator:||Alasdair M Barr, Ph.D||University of British Columbia|
|Principal Investigator:||Lili Kopala, M.D.||University of British Columbia|