NCT01504659终止2 期
Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder
Juvenile Bipolar Research Foundation2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Young Mania Rating Scale
研究概览
简要总结
The investigators plan to evaluate the efficacy and safety of intranasal Ketalar (ketamine hydrochloride) in the treatment of primary symptom manifestations of pediatric bipolar disorder; Fear of Harm (FOH) phenotype. This phenotype represents those children who are most resistant to traditional treatments and suffer repeated hospitalizations. Primary symptoms include fearfulness, aggression secondary to threat, mood and/or arousal instability, and psychosis. In addition to evaluation of efficacy and safety, the investigators will also analyze whether therapeutic response depends upon the degree to which the subject fits the FOH phenotype.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 6-12;
- •DSM-IV bipolar disorder (BPI, BPII, BP-NOS, BP-FOH);
- •Treatment resistant - as defined by failure to adequately respond to at least 2 different classes of medications such as mood stabilizers and antipsychotic agent.
排除标准
- •Contraindication to the use of ketamine, including allergy and current use of medicine contraindicated with ketamine;
- •Endocrine or neurological illness;
- •Previous history of closed head injury, current head injury associated with possible intracranial hypertension, central nervous system masses, abnormalities, or hydrocephalus, ever had loss of consciousness;
- •Previous history of glaucoma or acute globe injury
- •Abnormal nasal physiology which would not allow for adequate medication delivery;
- •Any change in medication type or dose within the past 30 days;
- •Treatment with any MAOI's currently or within the past 3 months;
- •Has had a course of ECT within the past 3 months;
- •Has ever used PCP or ketamine;
- •Meets DSM-IV criteria for Mental Retardation;
- •Has ever had Repetitive Transcranial Magnetic Stimulation (rTMS), Vagal Nerve Stimulation (VNS) or Deep Brain Stimulation;
- •Is currently hospitalized;
- •Has known or suspected schizophrenia, even if currently stable or controlled with medications
- •Is acutely suicidal or homicidal (i.e., in imminent danger with plan, urges and intent to harm oneself or others) including any serious attempts/those requiring hospitalization in the past 12 months or at the PI's discretion;
- •The presence of any abnormal laboratory findings or serious medical disorder or condition including: clinically significant organ system dysfunction; significant endocrine disease, including diabetes mellitus; hypothyroidism; cardiovascular disease (myocardial ischemia, heart failure, arrhythmias); coagulopathy; significant anemia; significant acute infection; glaucoma; dehydration; epilepsy; any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months; any diagnosed cardiac condition causing documented hemodynamic compromise or dysfunction of the SA or AV node; any diagnosed respiratory condition causing documented or clinically recognized hypoxia (e.g., chronic obstructive or restrictive pulmonary disease); body weight approximately < 80% or > 120% ideal body weight; or any medical condition known to interfere with cognitive performance; medication-related exclusions include narcotic therapy, chronic acetaminophen use, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, regularly dosed narcotics or any other sedative therapy or medication that interferes with SA or AV node function or could be considered contraindicated with the sedative properties of ketamine.
研究组 & 干预措施
Bipolar-Ketalar
Active Comparator
Children with a diagnosis of BP-I, BP-II or BP-NOS will receive 4 administrations of intranasal ketalar
干预措施: Ketamine hydrochloride injection (Drug)
Bipolar-Placebo
Placebo Comparator
Children with a diagnosis of BP-I, BP-II or BP-NOS will receive 4 administrations of placebo
干预措施: Flat tonic water (e.g., Canada Dry Tonic Water) (Drug)
结局指标
主要结局
Young Mania Rating Scale
时间窗: Change from baseline at 17 days
Overt Aggression Scale
时间窗: Change from baseline at day 17
Yale Brown Obsessive Compulsive Scale
时间窗: Change from baseline at Day 18, aggressive and obsessive questions
次要结局
- Wechsler Intelligence Scale for Children-IV(Change from baseline at day 18)
- SpO2(Change from baseline over 16 hours spanning days 6-7 and 15-16.)
- Delis-Kaplin Executive Function System(Change from baseline on day 18)
- SCARED(change from baseline at day 18)
- body temperature(Change from baseline over 16 hours spanning days 6-7 and 15-16.)
- Triaxial acceleration(Change from baseline over 16 hours spanning days 6-7 and 15-16.)
- Conner's Continuous Performance Test(Change from baseline on day 18)
- Peripheral Thermal Challenge(Change from baseline on days 6, 7, 15 and 16)
- Galvanic skin response(Change from baseline over 16 hours spanning days 6-7 and 15-16.)
研究者
研究点 (2)
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