A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Abdominal distribution of visceral fat versus subcutaneous fat
研究概览
简要总结
The purpose of this study is to compare abdominal weight gain and fat distribution in people taking aripiprazole versus risperidone or quetiapine, to people not taking any of these antipsychotic medications.
详细描述
Second generation antipsychotic drugs have much greater efficacy for refractory schizophrenia and have much lower propensity to induce motor side-effects. These medications are seeing increased use for indications other than psychosis, and greater use in populations such as adolescents. However, one of the most critical issues in the field of psychiatry today is the overwhelming evidence that chronic use of the second generation antipsychotics can result in metabolic dysregulation, which includes weight gain, hyperlipidemia, and insulin resistance. A recent meta-analysis indicated that switching from other second generation antipsychotics to the antipsychotic drug aripiprazole consistently resulted in significant weight loss and may be an optimal treatment for patients who exhibit drug-induced weight gain. Therefore, we aim to compare metabolic dysregulation (namely abdominal weight gain and fat distribution)in participants taking aripiprazole, to participants who are taking higher-metabolic propensity antipsychotic drugs (such as risperidone or quetiapine), and to healthy participants.
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 hospital for psychiatric services 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 no more than 12 weeks of total lifetime exposure to antipsychotics.
- •Participants may be in- or outpatients.
- •Participants able to give informed consent, or informed consent through legally authorized representative.
排除标准
- •Previous total lifetime exposure to antipsychotics of more than 12 weeks.
- •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 chemotherapy for cancer treatment in the 4 weeks prior to baseline or 16-week follow-up visit.
- •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 with at least 10mg aripiprazole per day, as prescribed to them by their psychiatrists.
干预措施: Aripiprazole (Drug)
Risperidone/Quetiapine
Participants receiving treatment with either risperidone or quetiapine, as prescribed to them by their psychiatrists.
干预措施: Risperidone/Quetiapine (Drug)
结局指标
主要结局
Abdominal distribution of visceral fat versus subcutaneous fat
时间窗: Baseline (within 12 weeks of starting antipsychotic treatment), and 16 weeks later
Change over time, and between groups, in amounts of visceral and subcutaneous fat as measured by automated segmentation of a magnetic resonance image (MRI).
次要结局
- Potential genetic factors of antipsychotic-induced weight gain(Sample to be taken after 16 weeks of participation in the study)
- Metabolic measures(Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later)
- Fat content of the liver(Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later)
- Glucose intolerance(Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later)