An interventional study of Ultrabrief pulse electroconvulsive therapy and Brief pulse Electroconvulsive therapy in Schizophrenia Disorders, sponsored by Hospital Psiquiátrico Fray Bernardino Álvarez. Terminated at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Hospital Psiquiátrico Fray Bernardino Álvarez · Not applicable, Interventional, and Treatment
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.
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
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 17 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
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A) Inclusion Criteria:
B)Exclusion Criteria:
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
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
Therapeutic seizure induction with pulse unidirectional electric charge through the right hemisphere, using ultrabrief pulses (≤0.3 ms).
Therapeutic seizure induction with pulse unidirectional electric charge through the temporal hemisferes, using brief pulses (≥0.5 ms).
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.
Time frame: 48 hours after last ECT session
Adverse effect incidence
The incidence of side effects will be expressed as the percentage of subjects affected within each study group.
Time frame: Between two hours and 24 hours after the last ECT session
Time to adverse event onset measured in number of sessions
Time to adverse event onset is defined as the number of completed ECT sessions where the outcome is first documented. Count of sessions from Session 1 (baseline) to the session where the AE is first documented.
Time frame: From the first session until 48 hours after last session
Cognitive changes measured by MoCA
Change in total Montreal Cognitive Assessment (MoCA) score at the end of treatment. Result will be analyzed as a continuous linear variable. MoCA evaluates 7 domains, with item-level binary scoring (0/1). Serial-7s allow up to 3 points (1 per correct subtraction). Total scores are interpreted against validated cutoffs. Cutoff: \<26/30 suggests impairment (adjusted for education ≤12 years: +1 point). Total Score: 0-30 (higher = better cognition).
Time frame: 48 hours after last ECT session
Cognitive changes measured by BACS
Change in Brief Assessment of Cognition in Schizophrenia (BACS) total score post-treatment. BACS is a neuropsychological battery designed to assess cognitive impairment in individuals with schizophrenia. Consists of 6 subtests, each assessing a specific cognitive domain. Raw scores are converted to standardized z-scores (mean = 0, SD = 1) based on normative data. Higher scores = Better cognitive performance.
Time frame: 48 hours after last ECT session
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf, Csr
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This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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