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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02334904
Other study ID # H14-01075
Secondary ID
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


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
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