Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: First-Episode Psychosis; Bipolar Disorder
Intervention: Aripiprazole (Drug); Risperidone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): Alasdair M Barr, Ph.D, Principal Investigator, Affiliation: University of British Columbia Lili Kopala, M.D., Principal Investigator, Affiliation: University of British Columbia
Overall contact: Heidi Boyda, Ph.D, Phone: 604-612-5025, Email: hnboyda@gmail.com
Summary
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.
Clinical Details
Official title: Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: MRI Brain Scans (Composite Measure)
Secondary outcome: Metabolic Fasting Blood Work (Composite Measures)Genetic Measures (Composite Measure) Neuropsychological Assessments Psychiatric Assessment
Detailed description:
The purpose of this study is to use a direct measure of brain volume and matter (by means of
MRI) to determine if there is a differential effect between aripiprazole and risperidone on
brain morphology in participants with first-episode psychosis. A secondary objective is to
see if fasting metabolic indices measured in the blood (i. e. glucose, insulin, total
cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, adiponectin and leptin) are
also correlated to changes in brain morphology or symptom severity (as measured by
neuropsychiatric assessments).
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female, aged 12+ years for healthy participants or participants with bipolar
disorder; or aged 15+ years for participants with non-affective psychosis.
- Recent admission to the Vancouver/Richmond Early Psychosis Intervention (EPI) program
related to first episode psychosis or first episode bipolar disorder;
- Participants being treated with an antipsychotic medication principally for psychosis
or for bipolar disorder.
- Participants taking aripiprazole must be taking a dose of at least 10mg/day for the
duration of the study.
- Participants must have received a minimum of 3 months of continuous antipsychotic
drug treatment with either aripiprazole or risperidone principally for psychosis or
bipolar disorder;
- Participants may be in- or outpatients.
- Participants able to give informed consent, or informed consent through legally
authorized representative.
Exclusion Criteria:
- Total life time exposure to the antipsychotic drug aripiprazole vs risperidone for
less than 3 months at time of consent.
- Previously diagnosed with diabetes mellitus, seizure disorders, mental retardation
(IQ < 70), or pregnancy (current or within 3 months postpartum)
- Participants who have been treated/are currently being treated with mood stabilizers
(paroxetine, lithium, or valproic acid). Prior or concurrent use of Selective
Serotonin Reuptake Inhibitor antidepressants (other than paroxetine) is acceptable..
- Received antipsychotic polypharmacy (treatment with more than one antipsychotic drug)
- Participants who are not able to fluently communicate in English.
- Contraindicated for MRI scan (i. e., has had major surgery in the last 6 months,
morbid obesity, claustrophobia, and/or has metal in their bodies from a surgical
intervention or working in metalwork, or is unsure if metal is present in their
bodies, etc.)
Locations and Contacts
Heidi Boyda, Ph.D, Phone: 604-612-5025, Email: hnboyda@gmail.com
BC Mental Health & Addictions Research Institute, Vancouver, British Columbia V5Z 4H4, Canada; Recruiting Delrae Fawcett, MSc, Phone: 604-875-2000, Ext: 6115, Email: delrae.fawcett@ubc.ca
Additional Information
Starting date: July 2014
Last updated: February 4, 2015
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