Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- MRI Brain Scans (Composite Measure)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.)
研究组 & 干预措施
Aripiprazole
Participants receiving treatment of only aripiprazole, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.
干预措施: Aripiprazole (Drug)
Risperidone
Participants receiving treatment of only risperidone, as prescribed to them by their psychiatrists, for a minimum of at least 3 continuous months.
干预措施: Risperidone (Drug)
结局指标
主要结局
MRI Brain Scans (Composite Measure)
时间窗: 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.
次要结局
- Metabolic Fasting Blood Work (Composite Measures)(Day 1 (Visit 1))
- Genetic Measures (Composite Measure)(Day 1 (Visit 1))
- Neuropsychological Assessments(At time of Day 1 (Only for those taking antipsychotic medications))
- Psychiatric Assessment(At time of Day 1 (Only for those taking antipsychotic medications))