NCT01082848Unknown3 期
Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial
Juan A. Arnaiz1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Eating Disorder Inventory-2
研究概览
简要总结
Evidence is lacking on the effects of different psychotropic drugs in the treatment of anorexia nervosa (AR). However, HVA levels seem to be elevated in this disease, therefore suggesting a role for drugs with a partial agonist profile on dopaminergic receptors. This is a pilot study assessing the effects of aripiprazole in teenagers with AR, compared with a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 12 and 18
- •diagnostic criteria for anorexia Nervosa (DSM-IV-TR (includes BMI below 17.5kg/m2 and above 14 kg/m2) confirmed by a Psychiatrist and validated by K-SADS-PL interview
- •severity criteria requiring Hospital admission
- •Consent given by parents and patients
排除标准
- •psychotic illness
- •antipsychotic therapy at inclusion
- •pregnancy and breastfeeding
- •antipsychotic drug allergy
- •prior head trauma, malignant neuroleptic syndrome or epilepsy
- •relevant comorbidities requiring therapy
- •detection of abuse drugs in urine test
- •treatment with neuroleptic, antidepressant or mood stabilizers during 2 weeks prior to randomization (4 weeks in case of fluoxetine)
- •suicidal or homicidal thoughts
- •IQ below 70
研究组 & 干预措施
aripiprazole
Experimental
干预措施: aripiprazole (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Eating Disorder Inventory-2
时间窗: 6 months
Eating attitudes test (EAT)
时间窗: 6 months
Brown Assessment of Beliefs Scale (BABS)
时间窗: 6 months
次要结局
- BMI(6 months)
- BDI(6 months)
研究者
Juan A. Arnaiz
Dr
Hospital Clinic of Barcelona
研究点 (1)
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