Psychopharmacological Treatment of Emotional Distress: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Suicide Crisis Syndrome-Checklist (SCS-C)
研究概览
简要总结
This is an inpatient four-arm randomized control trial comparing single drug clonazepam (S arm), a two-drug combination clonazepam/olanzapine (D arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (T arm) with treatment as usual (TAU arm) in the treatment of emotional distress, specifically the Suicide Crisis Syndrome (SCS). All participants in experimental arms receive 2-day pulse treatments targeting four out of five of the acute emotional distress symptoms. The primary outcome measure is SCS at discharge and one-month follow-up. The secondary outcome measures include questions about suicidal behaviors associated with emotional distress at a one-month follow-up.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted to an inpatient unit and ruled in for SCS diagnosis using SCS-C
- •Willing to stay in the hospital voluntarily, if medically necessary, for at least 4 days after enrolling in the study.
- •Patient admitted to an inpatient unit as a result of a recent (i.e., past-month) suicide attempt, as defined by the C-SSRS (Columbia Suicide Rating Scale).
- •Admitted to an inpatient unit in the last 36 hrs.
- •Able to understand the nature and the substance of the consent form.
- •Currently domiciled.
- •Able and willing to provide verifiable contact information for follow-up.
排除标准
- •Intellectual disability, cognitive impairment, or linguistic limitation precluding understanding of the consent or research questions.
- •Past adverse reactions to clonazepam, olanzapine, or buprenorphine
- •Past history of opiate or benzodiazepine use d/o in the last 2 years
- •On agonist therapy for opiate addiction
- •Ongoing treatment with clonazepam or olanzapine.
- •Significant medical or neurological disease or possible delirium that might interfere with study participation or capacity to provide informed consent.
- •Receiving involuntary treatment in psychiatric unit
- •Clinical suspicion of malingering by a CP.
- •Undomiciled.
研究组 & 干预措施
S arm: Single drug clonazepam
Single drug clonazepam: 1 mg a day (0.5 mg twice a day) with Treatment As Usual (TAU)
干预措施: Clonazepam (Drug)
D arm: Two-drug combination clonazepam/olanzapine
Two-drug combination clonazepam/olanzapine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine with Treatment As Usual (TAU)
干预措施: Clonazepam (Drug)
D arm: Two-drug combination clonazepam/olanzapine
Two-drug combination clonazepam/olanzapine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine with Treatment As Usual (TAU)
干预措施: Olanzapine (Drug)
T arm: Three-drug combination clonazepam/olanzapine/buprenorphine
Three-drug combination clonazepam/olanzapine/buprenorphine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine plus 2mg a day of Buprenorphine with Treatment As Usual (TAU)
干预措施: Clonazepam (Drug)
T arm: Three-drug combination clonazepam/olanzapine/buprenorphine
Three-drug combination clonazepam/olanzapine/buprenorphine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine plus 2mg a day of Buprenorphine with Treatment As Usual (TAU)
干预措施: Buprenorphine (Drug)
T arm: Three-drug combination clonazepam/olanzapine/buprenorphine
Three-drug combination clonazepam/olanzapine/buprenorphine: 1 mg a day (0.5 mg twice a day) of Clonazepam plus 2.5 mg a day of Olanzapine plus 2mg a day of Buprenorphine with Treatment As Usual (TAU)
干预措施: Olanzapine (Drug)
结局指标
主要结局
Suicide Crisis Syndrome-Checklist (SCS-C)
时间窗: up to 1 month follow up after discharge
The SCS-C is a clinician rated measure assessing clinicians' assessment of the presence and intensity of the Suicide Crisis Syndrome among their patients. The SCS-C includes 13 dichotomous items reflecting the presence or absence of the SCS symptoms. The SCS-C also assesses the presence of the five SCS criteria (entrapment, affective disturbances, loss of cognitive control, hyperarousal and social withdrawal). The first item is a clinician rating of entrapment (SCS criterion A), rated as yes or no. The second item assesses the 4 domains of SCS criterion B: affective disturbance, loss of cognitive control, hyperarousal, and social withdrawal. This item is rated yes if the patient exhibits 1 of the domains. A final rating is recorded as positive if both criteria A and B are rated as yes. A positive rating in the final rating reflects a positive SCS diagnosis.
次要结局
- Suicide Crisis Inventory-Short Form (SCI-SF) for Severity(up to 1 month follow up after discharge)
研究者
Igor Galynker
Clinical Professor
Icahn School of Medicine at Mount Sinai