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Trial record 52 of 408 for:    ARIPIPRAZOLE

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

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ClinicalTrials.gov Identifier: NCT02334904
Recruitment Status : Unknown
Verified May 2016 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : January 8, 2015
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
Vancouver Coastal Health
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date December 12, 2014
First Posted Date January 8, 2015
Last Update Posted Date June 1, 2016
Study Start Date July 2014
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 6, 2015)
MRI Brain Scans (Composite Measure) [ Time Frame: Day 1 (Visit 1) ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02334904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 6, 2015)
  • Metabolic Fasting Blood Work (Composite Measures) [ Time Frame: Day 1 (Visit 1) ]
    By obtaining two tubes of fasting blood, we will determine fasting metabolic parameters of common blood components (lipids, cholesterol, leptin, adiponectin, glucose, and insulin).
  • Genetic Measures (Composite Measure) [ Time Frame: Day 1 (Visit 1) ]
    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.
  • Neuropsychological Assessments [ Time Frame: At time of Day 1 (Only for those taking antipsychotic medications) ]
    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.
  • Psychiatric Assessment [ Time Frame: At time of Day 1 (Only for those taking antipsychotic medications) ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
Official Title Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
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.
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
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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.
Condition
  • First-Episode Psychosis
  • Bipolar Disorder
Intervention
  • Drug: Aripiprazole
    To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study)
    Other Name: Abilify
  • Drug: Risperidone
    To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
Study Groups/Cohorts
  • Aripiprazole
    Participants receiving treatment of only aripiprazole, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.
    Intervention: Drug: Aripiprazole
  • Risperidone
    Participants receiving treatment of only risperidone, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.
    Intervention: Drug: Risperidone
  • Controls
    Healthy participants who are not taking any antipsychotic medications.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 6, 2015)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility 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.)
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02334904
Other Study ID Numbers H14-01075
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of British Columbia
Study 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
PRS Account University of British Columbia
Verification Date May 2016