Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients

NCT01109147

Schizophrenia, Undifferentiated Type

COMPLETED PHASE4

Striatal Connectivity and Clinical Outcome in Psychosis

NCT02822092

Psychotic Disorders

COMPLETED

Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis

NCT00320671

Schizophrenia

COMPLETED PHASE4

Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia

NCT00712270

Schizophrenia

TERMINATED PHASE4

Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: 3-years Follow-up

NCT03883204

Schizophrenia Psychotic Disorders Psychosis

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

First-Episode Psychosis Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aripiprazole

Participants receiving treatment of only aripiprazole, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.

Aripiprazole

Intervention Type DRUG

To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study)

Risperidone

Participants receiving treatment of only risperidone, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.

Risperidone

Intervention Type DRUG

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.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aripiprazole

To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study)

Intervention Type DRUG

Risperidone

To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Abilify

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes