Clinical trial NCT06972745: Efficacy & Tolerability of Rigth Unilateral vs. Bitemporal ECT in Schizophrenia in a Psychiatric Hospital in Mexico
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia Disorders
Keywords: Electroconvulsive teraphy
Schizophrenia
Rigth unilateral
Cognition
Efficacy
Lead sponsor: Hospital Psiquiátrico Fray Bernardino Álvarez
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Outcomes: Efficacy: ≥30% PANSS reduction; Safety: Adverse event frequency/severity/time to adverse event onset. Cognition: MoCA and BACS pre-/post-ECT (administered by neuropsychology-trained staff).

Ethics: Conducted per WMA Declaration of Helsinki. Informed consent obtained from patients' legal guardians due to severe mental impairment in participants

Eligibility criteria: A) Inclusion Criteria:

1. Spanish-speaking.
2. any sex/gender.
3. Aged ≥18 years.

3. Diagnosis of schizophrenia per DSM-5 criteria. 4. Baseline PANSS (Positive and Negative Syndrome Scale) total score ≥60. 5. Treatment with 1-2 antipsychotics (including clozapine).

B)Exclusion Criteria:

1. Received ECT (electroconvulsive therapy) within the previous 3 months.
2. Comorbid affective disorders (e.g., bipolar disorder, major depressive disorder).
3. Catatonia or catatonic syndrome.
4. Pregnancy
5. Contraindications to general anesthesia/ECT (i.e. uncontrolled cardiovascular disease or intracranial hypertension).

Primary outcomes:
measure: Efficacy of electroconvulsive therapy technique
timeFrame: 48 hours after last ECT session
Secondary outcomes:
measure: Adverse effect incidence
timeFrame: Between two hours and 24 hours after the last ECT session
measure: Time to adverse event onset measured in number of sessions
timeFrame: From the first session until 48 hours after last session
measure: Cognitive changes measured by MoCA
timeFrame: 48 hours after last ECT session
measure: Cognitive changes measured by BACS
timeFrame: 48 hours after last ECT session
Other outcomes:
Locations:
city: México city
country: Mexico
facility: Hospital Psiquiátrico Fray Bernardino Álvarez
Study officials:
References: