Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
CARB
1 other identifier
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 12, 2014
CompletedFirst Posted
Study publicly available on registry
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 1, 2016
May 1, 2016
1.9 years
December 12, 2014
May 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (4)
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)
Study Arms (3)
Aripiprazole
Participants receiving treatment of only aripiprazole, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.
Risperidone
Participants receiving treatment of only risperidone, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.
Controls
Healthy participants who are not taking any antipsychotic medications.
Interventions
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).
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Vancouver Coastal Healthcollaborator
Study Sites (1)
BC Mental Health & Addictions Research Institute
Vancouver, British Columbia, V5Z 4H4, Canada
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alasdair M Barr, Ph.D
University of British Columbia
- PRINCIPAL INVESTIGATOR
Lili Kopala, M.D.
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2014
First Posted
January 8, 2015
Study Start
July 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 1, 2016
Record last verified: 2016-05