An Open-Label, Randomized, Active Controlled Inpatient Trial Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in PANSS-EC score at 120 minutes after medication administration
研究概览
简要总结
An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.
详细描述
This is an open-label, randomized control trial where patients (N=32) with schizophrenia or bipolar disorder are randomized to receive either sublingual dexmedetomidine or oral lorazepam monotherapy for the treatment of episodic agitation. For moderate agitation (PANSS-EC score ≥14 and <20), patients will receive either sublingual dexmedetomidine 120mcg or oral lorazepam 2mg. For severe agitation (PANSS-EC ≥20), patients will receive either sublingual dexmedetomidine 180mcg or oral lorazepam 2mg. The PANSS-EC and ACES will be evaluated at baseline and after 15, 30, 60, and 120 minutes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is an adult between the ages of 18-55 at the time of study participation
- •Hospitalized on an inpatient unit at Episcopal Hospital
- •Meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, as determined by routine clinical assessment conducted upon admission.
- •Are able to understand and read English
- •Are able to provide informed consent
- •Experiencing a moderate (PANSS-EC score ≥14 and <20) or severe (PANSS-EC score ≥20) episode of agitation
排除标准
- •Women who are pregnant or breastfeeding
- •Prisoners
- •Participant has an allergy to dexmedetomidine or lorazepam
- •Participant has mild, moderate or severe hepatic impairment
- •Participant has active pulmonary disease and is receiving treatment (oxygen, inhalers)
- •Individual is currently prescribed scheduled benzodiazepines or methadone
- •Participant history of QTc ≥ 500 msec or a history of arrythmia
- •Participant recent (within the last 2 days) fall, syncope (passing out), feeling lightheaded, or pulse <
- •Individual has a history of hypokalemia or hypomagnesemia within the past 2 years?
- •Participant is receiving high-risk medications, including:
- •High risk medications associated with the QT interval prolongation (sertindole, chlorpromazine, ziprasidone), (amiodarone, iboga, quinine, arsenic, ibutilide, selpercatinib, ivosidenib, bedaquiline, lenvatinib, sotalol, levoketoconazole, cisapride, vendetanib, mobocertinib, disopyramide, papaverine)
研究组 & 干预措施
Dexmedetomidine
Participants with moderate agitation will receive sublingual dexmedetomidine 120 mcg as needed. Participants with severe agitation will receive dexmedetomidine 180 mcg as needed.
干预措施: Dexmedetomidine (Drug)
Lorazapem
Participants with moderate agitation will receive oral lorazapam 2 mgas needed. Participants with severe agitation will receive oral lorazapam 2 mg as needed.
干预措施: Lorazepam 2 MG/ML (Drug)
结局指标
主要结局
Change in PANSS-EC score at 120 minutes after medication administration
时间窗: Baseline and at 120 minutes
Severity of agitation will be determined by administering the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC). Moderate to severe agitation will be defined as a PANSS-EC score \>=14 and \<20; and \>= 20 is severe agitation.
次要结局
- Change from baseline in ACES score at 15, 30, 60, 90, and 120 minutes, or prior to receipt of any rescue medication for agitation.(Baseline and 15, 30, 60, 90, and 120 minutes)
- Assess the need for rescue medication for agitation within two hours of medication administration(Baseline and 2 hours after medication administration)
- Patient tolerability assessed by adverse events of dexmedetomidine(Baseline through 120 minutes after medication administration)
- Change in PANSS-EC score at 15, 30, 60, and 90 minutes, or prior to receipt of any rescue medication for agitation.(Baseline and 15, 30, 60, and 90 minutes)
- Patient satisfaction based on Medication Satisfaction Questionnaire (MSQ)(Administered 120 minutes after medication administration)
研究者
Justin Faden
Associate Professor of Psychiatry
Temple University