Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI

Bipolar Disorder Clinical Trial

— CARB  

Official title:

Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02334904
• Other study ID #: H14-01075
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2014
• Last updated: May 30, 2016
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: University of British Columbia
• Contact: Heidi Boyda, Ph.D
• Phone: 604-612-5025
• Email: hnboyda[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• First-Episode Psychosis

Intervention

Drug:
• Aripiprazole
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study)
• Risperidone
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).

Locations

Country	Name	City	State
Canada	BC Mental Health & Addictions Research Institute	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Metabolic Fasting Blood Work (Composite Measures)	By obtaining two tubes of fasting blood, we will determine fasting metabolic parameters of common blood components (lipids, cholesterol, leptin, adiponectin, glucose, and insulin).	Day 1 (Visit 1)	No
Secondary	Genetic Measures (Composite Measure)	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.	Day 1 (Visit 1)	No
Secondary	Neuropsychological Assessments	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.	At time of Day 1 (Only for those taking antipsychotic medications)	No
Secondary	Psychiatric Assessment	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.	At time of Day 1 (Only for those taking antipsychotic medications)	No