Prospective Treatment Study of Catatonia Patients With Right Unilateral Electroconvulsive Treatment (RUL ECT) and Bilateral Electroconvulsive Treatment (BL ECT) Regimens
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Catatonia on the Bush- Francis Scale (BFCRS) - Pre
研究概览
简要总结
The purpose of this treatment study is to compare the effectiveness of different electrode placements used in Electroconvulsive Therapy (ECT) in the treatment of catatonia. In this study Electroconvulsive Therapy will be compared to medications used in the treatment of catatonia. Medications will be administered by the primary team as part of standard of care. Medications are not primarily being used as a part of this research study.
This treatments study, will be able to compare response rate of catatonia to right unilateral electroconvulsive treatment (RUL ECT) and Bilateral electroconvulsive treatment (BL ECT). Also having a control group of catatonia patients, which will not be treated with ECT will provide additional information on early ECT treatment of Catatonia.
详细描述
Catatonia was first described in 1873 by a German psychiatrist, Karl Ludwig Kahlbaum in his monograph titled ''Die Katatonie oder Das Spannungsirresein'' (Catatonia or tension insanity) (Kahlbaum, 1873). He conceptualized catatonia as a motor syndrome characterized by lack of motion, speech, alternating with periods of excessive purposeful motor activity, rigidity, negativism, verbigeration, automatic imbalance, posturing, grimacing and stereotypes. He also described that the syndrome generally had a periodic course and lethal outcome in a few. Despite a long history, "katatonia" was associated with different illnesses and was given as diagnostic specifier. DSM- V made a change and added catatonia as an independent diagnostic symptom.
According to DSM-V, catatonia is characterized by the following:
A. the clinical picture is dominated by 3 or more of the following symptoms
(1) Stupor (2) Catalepsy (3) Waxy flexibility (4) Mutism (5) Negativism (6) Posturing (7) Mannerism (8) Stereotypy (9) Agitation (10) Grimacing (11) Echolalia (12) Echopraxia
B. There is evidence from the history, physical examination or laboratory findings that the disturbance is in the direct patho-physiological consequence of another medical condition.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients admitted to WFBMC Inpatient Psychiatry unit with catatonia who are clinically eligible for ECT.
- •Clinical catatonia as evidenced by a Bush-Francis Catatonia Rating Scale (BFCRS) score of 4 or more
排除标准
- •Pregnant women
- •Patients with any of the following medical conditions which are contraindications for ECT:
- •Pheochromocytoma
- •History of stroke within the past 3 months
- •Cardiac conduction defects
- •Cerebral or aortic aneurysms
研究组 & 干预措施
Right unilateral (RUL) ECT
Right Unilateral placement of treatment electrodes in electroconvulsive treatment.
干预措施: Electroconvulsive Treatment (ECT) Right Unilateral (Device)
Bilateral (BL) ECT
Bilateral placement of treatment electrodes in electroconvulsive treatment.
干预措施: Electroconvulsive Treatment (ECT) - Bilateral (Device)
Control group
No ECT treatment for control group.
结局指标
主要结局
Catatonia on the Bush- Francis Scale (BFCRS) - Pre
时间窗: 1 day post first ECT treatment
Repetitive evaluation by the Bush- Francis Scale (BFCRS) - To assess excitement, immobility, mutism, staring, posturing/catalepsy, grimacing, echopraxia, stereotypy, mannerisms, verbigeration, rigidity, negativism, waxy flexibility, withdrawal, impulsivity, automatic obedience, mitgehen, gegenhalten, ambitendency, grasp reflex, preservation, combativeness and automatic abnormality. Contains 23 items rated using a scale of 0-3. Total Score 0-69. Higher scores denote worse outcomes.
次要结局
- Depression on the Hamilton Depression Scale(30 days)
- Cognitive Side Effects on Montreal Cognitive Assessment (MoCA)(30 days)