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

NCT06972745 | Terminated

• 1 other identifier: CI-962
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Disorders

Keywords

Electroconvulsive teraphy; Schizophrenia; Rigth unilateral; Cognition; Efficacy

Outcome Measures

Primary Outcomes (1)

• Efficacy of electroconvulsive therapy technique

  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.

  48 hours after last ECT session

Secondary Outcomes (4)

• 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

Study Arms (2)

Rigth unilateral electrode placement

EXPERIMENTAL

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).

Procedure: Ultrabrief pulse electroconvulsive therapy

Bitemporal electrode placement

ACTIVE COMPARATOR

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.

Procedure: Brief pulse Electroconvulsive therapy

Interventions

Ultrabrief pulse electroconvulsive therapy PROCEDURE

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

Rigth unilateral electrode placement

Brief pulse Electroconvulsive therapy PROCEDURE

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

Bitemporal electrode placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spanish-speaking.
• any sex/gender.
• Aged ≥18 years.
• \. 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).

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Psiquiátrico Fray Bernardino Álvarez: lead

Study Sites (1)

Hospital Psiquiátrico Fray Bernardino Álvarez

México, Mexico

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Psychiatrist, Psychiatric Emergency Department

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: May 15, 2025
• Study Start: March 16, 2023
• Primary Completion: October 16, 2024
• Study Completion: November 16, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting in January 2025
• Access Criteria: Access will be granted to researchers who contact the principal investigator directly

Locations

ME (1)