DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017