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Trial record 50 of 405 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

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.

Condition or disease Intervention/treatment
First-Episode Psychosis Bipolar Disorder 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).

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
Study Start Date : July 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

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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 Name: 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.


Biospecimen Retention:   Samples With DNA
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.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334904


Contacts
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Contact: Heidi Boyda, Ph.D 604-612-5025 hnboyda@gmail.com
Contact: Delrae Fawcett, MSc 604-875-2000 ext 6115 delrae.fawcett@ubc.ca

Locations
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Canada, British Columbia
BC Mental Health & Addictions Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z 4H4
Contact: Delrae Fawcett, MSc    604-875-2000 ext 6115    delrae.fawcett@ubc.ca   
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health
Investigators
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Principal Investigator: Alasdair M Barr, Ph.D University of British Columbia
Principal Investigator: Lili Kopala, M.D. University of British Columbia

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02334904     History of Changes
Other Study ID Numbers: H14-01075
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Aripiprazole
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists