Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI (CARB)

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.

Study Overview

• Status: Unknown
• Conditions: Bipolar Disorder; First-Episode Psychosis
• Intervention / Treatment: Drug: Aripiprazole; Drug: Risperidone

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).

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4H4
      • Recruiting
      • BC Mental Health & Addictions Research Institute
      • Contact: Delrae Fawcett, MSc; Phone Number: 6115 604-875-2000; Email: delrae.fawcett@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aripiprazole; Participants receiving treatment of only aripiprazole, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.	Drug: Aripiprazole; To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study); Other Names: Abilify
Risperidone; Participants receiving treatment of only risperidone, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.	Drug: Risperidone; To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
Controls; Healthy participants who are not taking any antipsychotic medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Vancouver Coastal Health
• Investigators: Principal Investigator: Alasdair M Barr, Ph.D, University of British Columbia; Principal Investigator: Lili Kopala, M.D., University of British Columbia

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: December 12, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 8, 2015

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 30, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole; Risperidone
• Other Study ID Numbers: H14-01075