Cohort Study on Efficacy and Tolerance of Right Unilateral Electroconvulsive Therapy vs. Bitemporal in Patients With Paranoid Schizophrenia in Acute Psychosis at Fray Bernardino Álvarez Psychiatric Hospital
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Efficacy of electroconvulsive therapy technique
研究概览
简要总结
Electroconvulsive therapy (ECT) is an established treatment for medication-resistant schizophrenia. There is debate about the best method of electrode placement. Bitemporal (BT) placement is commonly used for schizophrenia, while right unilateral (RUL) placement in mood disorders is associated with fewer adverse effects on memory and language. This study compares the efficacy, safety and cognitive effects of BT-ECT versus RUL-ECT in hospitalized schizophrenia patients with acute psychosis.
Main Question: Does RUL-ECT reduce psychotic symptoms with fewer cognitive effects versus BT-ECT in patients with severe schizophrenia? Hypothesis: RUL-ECT is as effective as BT-ECT in reducing psychotic symptoms with fewer cognitive effects.
Methods: Randomized trial in patients with schizophrenia (confirmed by DSM 5 criteria) and severe symptoms (PANSS score ≥60). Patients were assigned to receive BT-ECT or RUL-ECT. Efficacy was measured by a ≥30% reduction in symptom severity on the PANSS scale and overall improvement measured with the Clinical Global Impression scale. Cognitive function was assessed with the Montreal Cognitive Assessment (MoCA) and Brief Assessment of Cognition in Schizophrenia (BACS) scales.
详细描述
Study Design and Setting: Randomized experimental trial at Fray Bernardino Álvarez Psychiatric Hospital, Mexico City.
Sample Size: Quota sampling. Eligibility Criteria: inpatients, spanish-speaking, ≥18 years old with DSM-5 schizophrenia diagnosis, PANSS total score ≥60, and treatment with 1-2 antipsychotics (including clozapine). Exclusions: ECT within 3 months, affective comorbidities, catatonia, pregnancy, anesthesia/ECT contraindications, or incomplete follow-up.
Equipment and Technique: Pre-ECT evaluations included ECG, chest X-ray, blood tests, and assessments by internists/anesthesiologists. ECT was administered by a principal investigator (Emory University-certified) using a MECTA Corp spECTrum 5000Q device, 3x/week (excluding weekends). Electrode placement: bitemporal (BT) with brief pulses (≥0.5 ms) or right unilateral (RUL; D'Elia placement) with ultrabrief pulses (≤0.3 ms). Initial titration doses: 48 mC (BT) or 4.8 mC (RUL), doubled until adequate seizure (assessed via Clinical and Seizure Based Stimulation method). Maintenance doses: 2x threshold (BT) or 6x threshold (RUL), adjusted by 50% for poor-quality seizures. Premedication: atropine (1 mg IM), propofol (1 mg/kg IV), and succinylcholine (1 mg/kg IV).
Intervention and Comparator: Active comparator: BT-ECT vs. RUL-ECT.(intervention) No placebo group due to institutional constraints.
Randomization and Blinding: Block randomization (Microsoft Excel-generated) by an independent researcher. Allocation sequence concealed by an assistant and disclosed pre-treatment.
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
- Single (Participant)
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
- •A) Inclusion Criteria:
- •Spanish-speaking.
- •any sex/gender.
- •Aged ≥18 years.
- •Diagnosis of schizophrenia per DSM-5 criteria.
- •Baseline PANSS (Positive and Negative Syndrome Scale) total score ≥
- •Treatment with 1-2 antipsychotics (including clozapine).
排除标准
- •Received ECT (electroconvulsive therapy) within the previous 3 months.
- •Comorbid affective disorders (e.g., bipolar disorder, major depressive disorder).
- •Catatonia or catatonic syndrome.
- •Contraindications to general anesthesia/ECT (i.e. uncontrolled cardiovascular disease or intracranial hypertension).
研究组 & 干预措施
Rigth unilateral electrode placement
Anode (Right Temporal): Centered over the right temporal lobe, 2.5 cm (1 inch) above the midpoint of an imaginary line connecting the tragus and the external canthus.
Cathode (Right Parietal): Placed vertically 10 cm (4 inches) above the temporal electrode, aligned with the parietal bone (midline between the temporal and occipital regions).
干预措施: Ultrabrief pulse electroconvulsive therapy (Procedure)
Bitemporal electrode placement
Anode placed over the left temporal region: Positioned 2.5 cm (1 inch) above the midpoint of an imaginary line connecting the tragus (ear canal) and the external canthus (outer corner) of the left eye.
Catode positioned over the right temporal region: Mirror placement on the right side, symmetrically aligned with the left electrode.
干预措施: Brief pulse Electroconvulsive therapy (Procedure)
结局指标
主要结局
Efficacy of electroconvulsive therapy technique
时间窗: 48 hours after last ECT session
Treatment response is defined as a ≥20% reduction in the total score of the Positive and Negative Syndrome Scale (PANSS) after treatment. A dichotomous classification was applied (responders vs. non-responders) The PANSS assesses symptom severity through 30 items, each scored on a 1-7 scale, where: 1 = Absent (no symptom) and 7 = Extreme (severe symptom). Higher PANSS scores indicate greater symptom severity, meaning a lower score reflects a better clinical outcome.
次要结局
- Adverse effect incidence(Between two hours and 24 hours after the last ECT session)
- Time to adverse event onset measured in number of sessions(From the first session until 48 hours after last session)
- Cognitive changes measured by MoCA(48 hours after last ECT session)
- Cognitive changes measured by BACS(48 hours after last ECT session)
研究者
Héctor Octavio Castañeda González
Attending Psychiatrist, Psychiatric Emergency Department
Hospital Psiquiátrico Fray Bernardino Álvarez