First-Episode PsychosisCARBNCT02334904
Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
An observational study of First-Episode Psychosis and Bipolar Disorder, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- First-Episode Psychosis, Bipolar Disorder
- What is being tested?
- Aripiprazole and Risperidone
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Mental Health & Addictions Research Institute
Vancouver, British Columbia, V5Z 4H4
Delrae Fawcett, MSc, 604-875-2000 ext. 6115, delrae.fawcett@ubc.ca
About this study
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.
Read the 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).
- Conditions
- First-Episode Psychosis, Bipolar Disorder
- Being tested
- Aripiprazole, Risperidone
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called Abilify
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study)
RisperidoneDrug
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Participants receiving treatment of only aripiprazole, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months. Receives: 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. Receives: Drug: Risperidone | |
| Controls | Healthy participants who are not taking any antipsychotic medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (Visit 1)
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of Day 1 (Only for those taking antipsychotic medications)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startJul 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First-Episode PsychosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health
- Responsible party
- Sponsor
- Investigators
- Alasdair M Barr, Ph.D, Principal investigator, University of British ColumbiaLili Kopala, M.D., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334904
- Sponsor's protocol ID
- H14-01075
- Acronym
- CARB
- Status last verified
- May 2016
- First submitted
- 12 Dec 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
- ClinicalTrials.gov ID
- NCT02334904
- Acronym / sponsor ID
- CARB / H14-01075
- Conditions
- First-Episode Psychosis, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | – | Drug: AripiprazoleParticipants receiving treatment of only aripiprazole, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months. |
| Risperidone | – | Drug: RisperidoneParticipants receiving treatment of only risperidone, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months. |
| Controls | – | –Healthy participants who are not taking any antipsychotic medications. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAlso: AbilifyTo be prescribed and monitored by participant's attending physician (not given to participants as a part of the study) | Drug | Aripiprazole |
| RisperidoneTo be prescribed and monitored by participant's attending physician (not given to participants as a part of the study). | Drug | Risperidone |
Primary outcome
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.
4 secondary outcomes
Metabolic Fasting Blood Work (Composite Measures)
Time frame: Day 1 (Visit 1)
Genetic Measures (Composite Measure)
Time frame: Day 1 (Visit 1)
Neuropsychological Assessments
Time frame: At time of Day 1 (Only for those taking antipsychotic medications)
Psychiatric Assessment
Time frame: At time of Day 1 (Only for those taking antipsychotic medications)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
Related trials for First-Episode Psychosis
Recruiting
On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial
Sleep, Physical Activity
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
RecruitingPhase 3
Stratification and Treatment in Early Psychosis Study - ENHANCE
Psychosis, First Episode Psychosis
Active, not recruitingEarly Phase 1
Trial to Increase FEP Attendance
First-Episode Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alasdair M Barr, Ph.D principal investigator
University of British Columbia
Lili Kopala, M.D. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First-Episode Psychosis and Bipolar Disorder, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi Boyda, Ph.D (604-612-5025, hnboyda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Brain Scans (Composite Measure) (time frame: Day 1 (Visit 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.