Efficacy & Tolerability of Rigth Unilateral vs. Bitemporal ECT in Schizophrenia in a Psychiatric Hospital in Mexico

NCT ID: NCT06972745

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-16
• Study Completion Date: 2024-11-16

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

Conditions

Schizophrenia Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Ultrabrief pulse electroconvulsive therapy

Intervention Type: PROCEDURE

Therapeutic seizure induction with pulse unidirectional electric charge through the right hemisphere, using ultrabrief pulses (≤0.3 ms).

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.

Group Type: ACTIVE_COMPARATOR

Brief pulse Electroconvulsive therapy

Intervention Type: PROCEDURE

Therapeutic seizure induction with pulse unidirectional electric charge through the temporal hemisferes, using brief pulses (≥0.5 ms).

Interventions

Ultrabrief pulse electroconvulsive therapy

Therapeutic seizure induction with pulse unidirectional electric charge through the right hemisphere, using ultrabrief pulses (≤0.3 ms).

Intervention Type: PROCEDURE

Brief pulse Electroconvulsive therapy

Therapeutic seizure induction with pulse unidirectional electric charge through the temporal hemisferes, using brief pulses (≥0.5 ms).

Intervention Type: PROCEDURE

Eligibility Criteria

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).

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Psiquiátrico Fray Bernardino Álvarez

OTHER

Sponsor Role: lead

Responsible Party

Héctor Octavio Castañeda González

Attending Psychiatrist, Psychiatric Emergency Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Psiquiátrico Fray Bernardino Álvarez

México, , Mexico

Countries

Mexico

Other Identifiers

CI-962

Identifier Type: -

Identifier Source: org_study_id